Primary completion· ClinicalTrials.gov
A Phase 3 Study Comparing TLL-018 to Tofacitinib in RA Subjects With Inadequate Response or Intolerance to bDMARDs
Tofacitinib History and Updates
242 events · 2004 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
51
FDA Approvals
12
Label Revisions
639
Trial Milestones
7
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-07-15Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Tofacitinib since 2004, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (39)
2026
- Label revisionXeljanz XR Label Updated with Boxed Warning for Serious Risks· Jul 12, 2026
- Label revisionTofacitinib Boxed Warning Revised for Serious Risks· Jul 6, 2026
- Results postedTofacitinib in Recurrent Glioblastoma Shows No Radiographic Response· Jun 29, 2026
- Label revisionTofacitinib (Xeljanz) Label Adds Boxed Warning on Serious Risks· Jun 24, 2026
- Label revisionTofacitinib Label Adds Boxed Warning for Serious Infections, Mortality· Jun 9, 2026
- Label revisionTofacitinib (Xeljanz) Label Adds Boxed Warning for Serious Risks· Jun 8, 2026
- Label revisionTofacitinib Label Receives Boxed Warning for Serious Risks· Jun 5, 2026
- Label revisionTofacitinib Label Adds Boxed Warning for Serious Infections, Mortality, MACE,…· Jun 4, 2026
- Label revisionTofacitinib (Xeljanz) Label Adds Boxed Warning for Serious Risks· Jun 2, 2026
- Label revisionTofacitinib (Xeljanz) Label Adds Boxed Warning for Serious Risks· May 31, 2026
- Results postedTofacitinib Long-Term Safety in JIA: Lab Abnormalities, TEAEs Reported· Mar 23, 2026
- FDA approval (supplemental)Xeljanz XR (Tofacitinib) Receives Supplemental FDA Approval for Efficacy· Mar 6, 2026
- FDA approval (supplemental)Tofacitinib (Xeljanz) Receives FDA Supplemental Efficacy Approval· Mar 6, 2026
- FDA approval (supplemental)Xeljanz (Tofacitinib) Receives FDA Supplemental Approval for Efficacy· Mar 6, 2026
- Primary completionTofacitinib Phase 3 Study in Rheumatoid Arthritis Reaches Primary Completion· Jan 15, 2026
2025
- Results postedTofacitinib in Sjogren's Syndrome: Trial Shows Higher Adverse Event Count· Dec 18, 2025
- Results postedTofacitinib Reduces IFN Signaling, Improves Skin Conditions in Down Syndrome· Dec 11, 2025
- FDA approval (supplemental)Xeljanz (Tofacitinib) Receives FDA Supplemental Approval for Efficacy· Oct 16, 2025
- FDA approval (supplemental)Xeljanz (Tofacitinib) Receives FDA Supplemental Efficacy Approval· Oct 16, 2025
- Primary completionTofacitinib Phase 3 Trial for Polymyalgia Rheumatica Reaches Primary Completion· Sep 30, 2025
- Results postedTofacitinib Trial for SJS/TEN Shows Median 10-Day Healing, Zero Mortality· Sep 16, 2025
- Results postedTofacitinib Shows Lower Rheumatoid Arthritis Remission Rates vs. Abatacept· Jul 31, 2025
- Primary completionTofacitinib Phase 3 Trial in Takayasu's Arteritis Reaches Primary Completion· Jul 20, 2025
- Primary completionTofacitinib Trial in Recurrent Glioblastoma Reaches Primary Completion· Jun 16, 2025
- Results postedTofacitinib Trial Results Posted for Systemic Juvenile Idiopathic Arthritis· Jun 3, 2025
- Results postedTofacitinib Pilot Study for Frontal Fibrosing Alopecia Posts Results· May 30, 2025
- Results postedTofacitinib Trial for Moderate COVID-19 Pneumonia Terminated· Mar 28, 2025
- Results postedTofacitinib Phase 1 Trial for Cutaneous Lupus Shows Reduced Apoptotic Cells· Mar 21, 2025
- Primary completionTofacitinib Phase 3 Trial in Rheumatoid Arthritis Reaches Primary Completion· Feb 28, 2025
- FDA approval (supplemental)Tofacitinib (Xeljanz) Gains Supplemental Efficacy Approval· Feb 21, 2025
- FDA approval (supplemental)Xeljanz XR (Tofacitinib) Gains Supplemental FDA Approval for Efficacy· Feb 21, 2025
- Primary completionTofacitinib Phase 3 Glioblastoma Trial Shows No Radiographic Response· Feb 18, 2025
2022
- Pivotal publicationTofacitinib Phase 3 Trial for Juvenile Idiopathic Arthritis Published· Jan 1, 2022
- Pivotal publicationTofacitinib: Polymyalgia Rheumatica Induction/Tapering Therapy Trial Published· Jan 1, 2022
2021
- Pivotal publicationTofacitinib Results Published for Hospitalized COVID-19 Pneumonia· Jan 1, 2021
2017
- Pivotal publicationTofacitinib Pivotal Study Results Published for Ulcerative Colitis· Jan 1, 2017
- Pivotal publicationTofacitinib Psoriatic Arthritis Trial Results vs Adalimumab, Placebo Published· Jan 1, 2017
- Pivotal publicationTofacitinib Publishes Pivotal Psoriatic Arthritis Data vs. Methotrexate· Jan 1, 2017
2010
- Pivotal publicationTofacitinib: Pivotal Publication on Rituximab vs Cyclophosphamide for ANCA…· Jan 1, 2010
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis
Trial started· ClinicalTrials.gov
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
Primary completion· ClinicalTrials.gov
Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA)
Primary completion· ClinicalTrials.gov
Major Adverse Cardiovascular Events (MACE) in Rheumatoid Arthritis Patient With Moderate to Severe Disease Activity Treated With Tofacitinib
Trial started· ClinicalTrials.gov
A Precision Medicine Trial for Patients With Relapsed or Refractory T Cell ALL
Primary completion· ClinicalTrials.gov
Efficacy of Tofacitinib, Methotrexate Combination Therapy Versus Upadacitinib, Methotrexate Combination Therapy in Moderate to Severe Rheuma
Primary completion· ClinicalTrials.gov
Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis
Primary completion· ClinicalTrials.gov
A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, a
Primary completion· ClinicalTrials.gov
A Randomized Trial Comparing the Efficacy and Safety of Secukinumab with Tofacitinib in the Treatment of Moderate to Severe Hidradenitis Sup
Primary completion· ClinicalTrials.gov
Comparison of Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
Primary completion· ClinicalTrials.gov
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Primary completion· ClinicalTrials.gov
Comparison of Efficacy and Safety Psoralen Combined With Ultraviolet A (PUVA) Vs Tofacitinib in the Treatment of Generalized Vitiligo.
Primary completion· ClinicalTrials.gov
Prediction Model for Response to Biologics and Small Molecular Agent for UC
Primary completion· ClinicalTrials.gov
Effective Treatment of Jak1/3 Inhibitor in Blau Syndrome
Primary completion· ClinicalTrials.gov
Tofacitinib in Juvenile Idiopathic Arthritis
Primary completion· ClinicalTrials.gov
Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study
Primary completion· ClinicalTrials.gov
Therapies for Down Syndrome Regression Disorder
Primary completion· ClinicalTrials.gov
Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus
Primary completion· ClinicalTrials.gov
Topical Use of 2% Tofacitinib for Nail Psoriasis: an Exploratory Clinical Study
Primary completion· ClinicalTrials.gov
A Study of Iguratimod in Combination With Tofacitinib in RA Patients
Primary completion· ClinicalTrials.gov
Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis
Primary completion· ClinicalTrials.gov
Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis
Primary completion· ClinicalTrials.gov
Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial
Primary completion· ClinicalTrials.gov
A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, a
Primary completion· ClinicalTrials.gov
The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib an
Primary completion· ClinicalTrials.gov
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
Primary completion· ClinicalTrials.gov
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis
Primary completion· ClinicalTrials.gov
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Primary completion· ClinicalTrials.gov
Tofacitinib for Glucocorticoid-Resistant Moderate-to-Severe Thyroid Eye Disease
Primary completion· ClinicalTrials.gov
A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat In
Primary completion· ClinicalTrials.gov
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Primary completion· ClinicalTrials.gov
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
Primary completion· ClinicalTrials.gov
A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combined With Imatinib in Patients With Moderate-t
Primary completion· ClinicalTrials.gov
Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis
Primary completion· ClinicalTrials.gov
JAK Inhibitor Dose TAPering Strategy Study
Primary completion· ClinicalTrials.gov
A Precision Medicine Trial for Patients With Relapsed or Refractory T Cell ALL
Primary completion· ClinicalTrials.gov
Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis
Primary completion· ClinicalTrials.gov
Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis
Primary completion· ClinicalTrials.gov
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
Primary completion· ClinicalTrials.gov
Modulation of the Immune System in Down Syndrome for Improved Outcomes and Neurodevelopment - 1
Primary completion· ClinicalTrials.gov
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Past events
2026
Label revision· FDA
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS See full prescribing information
Label revision· FDA
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib tablets are at increased risk for developing serious bacterial, fungal, viral, and
Primary completion· ClinicalTrials.gov
A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on
Primary completion· ClinicalTrials.gov
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Primary completion· ClinicalTrials.gov
Korean Post-marketing Surveillance for Xeljanz XR
Results posted· ClinicalTrials.gov
Tofacitinib in Recurrent GBM Patients
Label revision· FDA
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib extended-release tablets are at increased risk for developing serious bacterial, fu
Label revision· FDA
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib oral solution are at increased risk for developing serious bacterial, fungal, viral
Label revision· FDA
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib extended-release tablets are at increased risk for developing serious bacterial, fu
Label revision· FDA
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib extended-release tablets are at increased risk for developing serious bacterial, fu
Label revision· FDA
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib tablets are at increased risk for developing serious bacterial, fungal, viral, and
Label revision· FDA
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib extended-release tablets are at increased risk for developing serious bacterial, fu
Label revision· FDA
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib tablets are at increased risk for developing serious bacterial, fungal, viral, and
Label revision· FDA
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib tablets are at increased risk for developing serious bacterial, fungal, viral, and
Label revision· FDA
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib tablets are at increased risk for developing serious bacterial, fungal, viral, and
Trial started· ClinicalTrials.gov
Comparison of Efficacy and Safety Psoralen Combined With Ultraviolet A (PUVA) Vs Tofacitinib in the Treatment of Generalized Vitiligo.
Trial started· ClinicalTrials.gov
Comparison of Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
Primary completion· ClinicalTrials.gov
Tocilizumab and Tofacitinib in the Treatment of Vascular Behçet's Syndrome
Trial started· ClinicalTrials.gov
Modulation of the Immune System in Down Syndrome for Improved Outcomes and Neurodevelopment - 1
Label revision· FDA
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib oral solution is at increased risk for developing serious bacterial, fungal, viral,
Trial registered· ClinicalTrials.gov
Modulation of the Immune System in Down Syndrome for Improved Outcomes and Neurodevelopment - 1
Trial registered· ClinicalTrials.gov
Comparison of Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
Primary completion· ClinicalTrials.gov
Therapies for Down Syndrome Regression Disorder
Primary completion· ClinicalTrials.gov
Safety and Efficacy of Tofacitinib for Chronic Granulomatous Disease With Inflammatory Complications
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
Trial started· ClinicalTrials.gov
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis
Primary completion· ClinicalTrials.gov
Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis
Trial registered· ClinicalTrials.gov
Major Adverse Cardiovascular Events (MACE) in Rheumatoid Arthritis Patient With Moderate to Severe Disease Activity Treated With Tofacitinib
Trial started· ClinicalTrials.gov
Tofacitinib for Glucocorticoid-Resistant Moderate-to-Severe Thyroid Eye Disease
Trial registered· ClinicalTrials.gov
Tofacitinib for Glucocorticoid-Resistant Moderate-to-Severe Thyroid Eye Disease
Trial registered· ClinicalTrials.gov
A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combined With Imatinib in Patients With Moderate-t
Trial registered· ClinicalTrials.gov
A Precision Medicine Trial for Patients With Relapsed or Refractory T Cell ALL
Trial started· ClinicalTrials.gov
A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combined With Imatinib in Patients With Moderate-t
Trial started· ClinicalTrials.gov
Topical Use of 2% Tofacitinib for Nail Psoriasis: an Exploratory Clinical Study
Primary completion· ClinicalTrials.gov
Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In Sweden
Results posted· ClinicalTrials.gov
Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis
Trial registered· ClinicalTrials.gov
A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat In
Trial registered· ClinicalTrials.gov
Efficacy of Tofacitinib on Skin Thickening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate
FDA approval (supplemental)· FDA
Sponsor: PFIZER. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: PF PRISM CV. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: PFIZER. Class: Efficacy.
Trial started· ClinicalTrials.gov
Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA)
Trial registered· ClinicalTrials.gov
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis
Trial registered· ClinicalTrials.gov
Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA)
Trial started· ClinicalTrials.gov
The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib an
Trial registered· ClinicalTrials.gov
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
Primary completion· ClinicalTrials.gov
A Phase 3 Study Comparing TLL-018 to Tofacitinib in RA Subjects With Inadequate Response or Intolerance to bDMARDs
Primary completion· ClinicalTrials.gov
Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
Trial registered· ClinicalTrials.gov
The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib an
Trial started· ClinicalTrials.gov
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Trial started· ClinicalTrials.gov
A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat In
Trial started· ClinicalTrials.gov
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
Trial started· ClinicalTrials.gov
Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial
2025
Trial registered· ClinicalTrials.gov
Topical Use of 2% Tofacitinib for Nail Psoriasis: an Exploratory Clinical Study
Primary completion· ClinicalTrials.gov
Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis
Primary completion· ClinicalTrials.gov
Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events
Trial started· ClinicalTrials.gov
Tofacitinib in Juvenile Idiopathic Arthritis
Primary completion· ClinicalTrials.gov
TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS
Trial registered· ClinicalTrials.gov
Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial
Trial started· ClinicalTrials.gov
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Results posted· ClinicalTrials.gov
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome
Trial registered· ClinicalTrials.gov
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Results posted· ClinicalTrials.gov
Tofacitinib for Immune Skin Conditions in Down Syndrome
Primary completion· ClinicalTrials.gov
Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
Primary completion· ClinicalTrials.gov
Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis
Trial started· ClinicalTrials.gov
Major Adverse Cardiovascular Events (MACE) in Rheumatoid Arthritis Patient With Moderate to Severe Disease Activity Treated With Tofacitinib
Trial registered· ClinicalTrials.gov
Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
Primary completion· ClinicalTrials.gov
Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis
Primary completion· ClinicalTrials.gov
Tofacitinib in Patients With Amyotrophic Lateral Sclerosis
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Dupilumab in Combination With Tofacitinib in Moderate to Severe Adult AD Patients
Primary completion· ClinicalTrials.gov
The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis
Primary completion· ClinicalTrials.gov
Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction
Primary completion· ClinicalTrials.gov
A Prospective Cohort Study on Primary Cutaneous Amyloidosis
FDA approval (supplemental)· FDA
Sponsor: PFIZER. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: PF PRISM CV. Class: Efficacy.
Trial started· ClinicalTrials.gov
Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus
Trial registered· ClinicalTrials.gov
Tofacitinib in Juvenile Idiopathic Arthritis
Primary completion· ClinicalTrials.gov
Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica
Primary completion· ClinicalTrials.gov
Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In Sweden
Trial started· ClinicalTrials.gov
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Primary completion· ClinicalTrials.gov
Efficacy of Oral Tofacitinib in Combination of Narrow Band UVB in Treatment of Vitiligo
Results posted· ClinicalTrials.gov
Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN
Primary completion· ClinicalTrials.gov
Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment With 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis
Primary completion· ClinicalTrials.gov
Efficacy of Tofacitinib on Skin Thickening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate
Trial started· ClinicalTrials.gov
Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
Trial registered· ClinicalTrials.gov
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Trial registered· ClinicalTrials.gov
Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus
Trial registered· ClinicalTrials.gov
Rhofanib® (Tofacitinib) Safety and Effectiveness Evaluation
Trial started· ClinicalTrials.gov
A Study of Iguratimod in Combination With Tofacitinib in RA Patients
Results posted· ClinicalTrials.gov
A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis
Primary completion· ClinicalTrials.gov
A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for Atopic Dermatitis
Primary completion· ClinicalTrials.gov
Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis
Trial registered· ClinicalTrials.gov
Comparison of Efficacy and Safety Psoralen Combined With Ultraviolet A (PUVA) Vs Tofacitinib in the Treatment of Generalized Vitiligo.
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis
Trial registered· ClinicalTrials.gov
Efficacy of Oral Tofacitinib in Combination of Narrow Band UVB in Treatment of Vitiligo
Primary completion· ClinicalTrials.gov
Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN
Primary completion· ClinicalTrials.gov
Tofacitinib in Recurrent GBM Patients
Primary completion· ClinicalTrials.gov
Rhofanib® (Tofacitinib) Safety and Effectiveness Evaluation
Trial registered· ClinicalTrials.gov
Efficacy of Tofacitinib, Methotrexate Combination Therapy Versus Upadacitinib, Methotrexate Combination Therapy in Moderate to Severe Rheuma
Trial started· ClinicalTrials.gov
Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis
Results posted· ClinicalTrials.gov
A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
Primary completion· ClinicalTrials.gov
Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma
Trial started· ClinicalTrials.gov
Efficacy and Safety of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
Trial registered· ClinicalTrials.gov
A Prospective Cohort Study on Primary Cutaneous Amyloidosis
Results posted· ClinicalTrials.gov
Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study
Trial registered· ClinicalTrials.gov
Efficacy and Safety of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
Trial started· ClinicalTrials.gov
Efficacy of Tofacitinib, Methotrexate Combination Therapy Versus Upadacitinib, Methotrexate Combination Therapy in Moderate to Severe Rheuma
Trial registered· ClinicalTrials.gov
A Study of Iguratimod in Combination With Tofacitinib in RA Patients
Trial started· ClinicalTrials.gov
A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for Atopic Dermatitis
Trial registered· ClinicalTrials.gov
A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for Atopic Dermatitis
Primary completion· ClinicalTrials.gov
Advanced Therapeutics in Rheumatoid Arthritis (RA)
Primary completion· ClinicalTrials.gov
ToFAcitinib in Early Active Axial SpondyloarThritis:
Results posted· ClinicalTrials.gov
Tofacitinib for Treatment of Moderate COVID-19
Results posted· ClinicalTrials.gov
Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus
Trial started· ClinicalTrials.gov
A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, a
Trial started· ClinicalTrials.gov
A Prospective Cohort Study on Primary Cutaneous Amyloidosis
Trial started· ClinicalTrials.gov
Efficacy of Oral Tofacitinib in Combination of Narrow Band UVB in Treatment of Vitiligo
Primary completion· ClinicalTrials.gov
A Phase 3 Study Comparing TLL-018 to Tofacitinib in RA Subjects With Inadequate Response or Intolerance to bDMARDs
FDA approval (supplemental)· FDA
Sponsor: PF PRISM CV. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: PFIZER. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: PFIZER. Class: Efficacy.
Primary completion· ClinicalTrials.gov
Tofacitinib in Recurrent GBM Patients
Primary completion· ClinicalTrials.gov
Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis
Trial registered· ClinicalTrials.gov
Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment With 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis
Trial started· ClinicalTrials.gov
Efficacy and Safety of Dupilumab in Combination With Tofacitinib in Moderate to Severe Adult AD Patients
Primary completion· ClinicalTrials.gov
Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients
Primary completion· ClinicalTrials.gov
Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis
Primary completion· ClinicalTrials.gov
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome
Trial started· ClinicalTrials.gov
JAK Inhibitor Dose TAPering Strategy Study
2024
Primary completion· ClinicalTrials.gov
Identification of Predictive Biomarkers for Response to Biologic Therapies and Tofacitinib in Inflammatory Bowel Disease
Primary completion· ClinicalTrials.gov
Tofatib Treatment for IgG4-related Disease
Trial started· ClinicalTrials.gov
Efficacy of Tofacitinib on Skin Thickening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate
Trial started· ClinicalTrials.gov
Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment With 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis
Trial started· ClinicalTrials.gov
A Randomized Trial Comparing the Efficacy and Safety of Secukinumab with Tofacitinib in the Treatment of Moderate to Severe Hidradenitis Sup
Trial started· ClinicalTrials.gov
Tofacitinib in Patients With Amyotrophic Lateral Sclerosis
Trial registered· ClinicalTrials.gov
A Randomized Trial Comparing the Efficacy and Safety of Secukinumab with Tofacitinib in the Treatment of Moderate to Severe Hidradenitis Sup
Trial registered· ClinicalTrials.gov
A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, a
Trial registered· ClinicalTrials.gov
Tofacitinib in Patients With Amyotrophic Lateral Sclerosis
Trial registered· ClinicalTrials.gov
Effective Treatment of Jak1/3 Inhibitor in Blau Syndrome
Trial registered· ClinicalTrials.gov
JAK Inhibitor Dose TAPering Strategy Study
Trial started· ClinicalTrials.gov
TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS
Primary completion· ClinicalTrials.gov
Tofacitinib for Immune Skin Conditions in Down Syndrome
Results posted· ClinicalTrials.gov
Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis
Trial registered· ClinicalTrials.gov
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Results posted· ClinicalTrials.gov
Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active
Primary completion· ClinicalTrials.gov
Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis
Trial registered· ClinicalTrials.gov
TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS
Results posted· ClinicalTrials.gov
IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis
Primary completion· ClinicalTrials.gov
Tofacitinib Associated With Meglumine Antimoniate in Cutaneous Leishmaniasis
Primary completion· ClinicalTrials.gov
3T Therapy in the Treatment of MDA5-positive Dermatomyositis
FDA approval (supplemental)· FDA
Sponsor: PF PRISM CV. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: PFIZER. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: PFIZER. Class: Labeling.
Trial started· ClinicalTrials.gov
Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis
Trial registered· ClinicalTrials.gov
Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study
Results posted· ClinicalTrials.gov
Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus
Trial started· ClinicalTrials.gov
Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study
Primary completion· ClinicalTrials.gov
A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis
Trial registered· ClinicalTrials.gov
A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on
Primary completion· ClinicalTrials.gov
Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study
Primary completion· ClinicalTrials.gov
Comparison of Tofacitinib and Methotrexate in the Maintained Treatment of GPA
Trial started· ClinicalTrials.gov
The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis
Primary completion· ClinicalTrials.gov
To Compare the Efficacy and Safety of Low-dose Glucocorticoids and Tofacitinib in Alleviating Moderate to High Disease Activity Rheumatoid A
Primary completion· ClinicalTrials.gov
Baricitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Comparison With Tofacitinib
Trial started· ClinicalTrials.gov
A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on
Trial registered· ClinicalTrials.gov
Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN
Trial registered· ClinicalTrials.gov
Efficacy and Safety of Dupilumab in Combination With Tofacitinib in Moderate to Severe Adult AD Patients
Trial started· ClinicalTrials.gov
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
Trial registered· ClinicalTrials.gov
3T Therapy in the Treatment of MDA5-positive Dermatomyositis
Primary completion· ClinicalTrials.gov
Effectiveness of Tofacitinib in Systemic Sclerosis
Trial registered· ClinicalTrials.gov
A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis
Trial started· ClinicalTrials.gov
A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis
FDA approval (supplemental)· FDA
Sponsor: PF PRISM CV. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: PFIZER. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: PFIZER. Class: Labeling.
Primary completion· ClinicalTrials.gov
Efficacy and Safety Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis.
Trial started· ClinicalTrials.gov
Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis
Trial registered· ClinicalTrials.gov
The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis
Trial started· ClinicalTrials.gov
Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis
Results posted· ClinicalTrials.gov
Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.
Results posted· ClinicalTrials.gov
Tofacitinib For Treatment Of Chronic Pouchitis
Primary completion· ClinicalTrials.gov
COVID-19 VaccinE Response in Rheumatology Patients
Primary completion· ClinicalTrials.gov
Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Pa
Primary completion· ClinicalTrials.gov
A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
Primary completion· ClinicalTrials.gov
Safety And Efficacy Of Tofacitinib In Patients With Refractory Myasthenia Gravis: A Pilot Study
Trial started· ClinicalTrials.gov
3T Therapy in the Treatment of MDA5-positive Dermatomyositis
Trial registered· ClinicalTrials.gov
Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study
Trial registered· ClinicalTrials.gov
Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis
Primary completion· ClinicalTrials.gov
Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease.
Primary completion· ClinicalTrials.gov
Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study
Trial registered· ClinicalTrials.gov
Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi.
Trial started· ClinicalTrials.gov
Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis
Primary completion· ClinicalTrials.gov
Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus
Results posted· ClinicalTrials.gov
Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis
Trial started· ClinicalTrials.gov
Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica
Primary completion· ClinicalTrials.gov
Tofacitinib for the Treatment of Refractory Immune-related Colitis from Checkpoint Inhibitor Therapy- TRICK Study
Trial registered· ClinicalTrials.gov
Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis
Trial registered· ClinicalTrials.gov
Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study
Primary completion· ClinicalTrials.gov
Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi.
2023
Primary completion· ClinicalTrials.gov
Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.