Primary completion· ClinicalTrials.gov
Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants
Adalimumab History and Updates
249 events · 2002 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
155
FDA Approvals
7
Label Revisions
1,387
Trial Milestones
5
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-07-13Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Adalimumab since 2002, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (26)
2026
- Label revisionAdalimumab Label Updated with Boxed Warning for Serious Infections, Malignancy· Jul 8, 2026
- Label revisionAdalimumab (Yuflyma) Boxed Warning Revised for Serious Infections, Malignancy· Jul 8, 2026
- Label revisionAdalimumab (Yuflyma) Label Adds Boxed Warning for Serious Infections and…· Jul 1, 2026
- Results postedAdalimumab Trial Measures PASI, DLQI in Chronic Plaque Psoriasis· Jun 24, 2026
- Results postedAdalimumab Comparator Trial for Crohn's Disease Posts Brazikumab PK Data· Jun 23, 2026
- Label revisionAdalimumab (HADLIMA) Label Adds Boxed Warning for Serious Infections· May 14, 2026
- Label revisionCyltezo (Adalimumab) Label Revised to Include Boxed Warning· Mar 3, 2026
- Results postedAdalimumab Biosimilar CHS-1420 Shows PK Similarity to Humira in Healthy Adults· Jan 9, 2026
2025
- Label revisionSimlandi Label Adds Boxed Warning for Serious Infections and Malignancy· Dec 22, 2025
- Results postedAdalimumab Early TNF Inhibition Improves Psoriatic Arthritis Disease Activity· Nov 26, 2025
- Results postedAdalimumab: Pediatric Ulcerative Colitis Trial Reports Long-Term Safety,…· Oct 16, 2025
- Results postedAdalimumab: Higher JIA ACR Responses Than Ixekizumab in Pediatric Trial· Jun 5, 2025
- FDA approval (supplemental)FDA Approves Adalimumab-Adbm Supplemental Efficacy Application· May 20, 2025
- FDA approval (supplemental)Amjevita (adalimumab-atto) Receives FDA Supplemental Efficacy Approval· May 20, 2025
- Results postedAdalimumab Shows Superior Corticosteroid-Sparing in Uveitis Trial· May 16, 2025
- Results postedAdalimumab: AScalate Trial Shows SOC Better for Axial Spondyloarthritis· Apr 16, 2025
- Primary completionAdalimumab Phase 3 Long-term Study in Pediatric Ulcerative Colitis Completes· Apr 8, 2025
- FDA approval (supplemental)Amjevita (adalimumab-atto) Receives FDA Supplemental Efficacy Approval· Apr 7, 2025
- Primary completionAdalimumab Phase 3 Trial for Plaque Psoriasis Completes Primary Period· Mar 31, 2025
- Results postedAdalimumab: Stopping Treatment Increases JIA-associated Uveitis Failure Risk· Mar 26, 2025
- Results postedAdalimumab: RA Trial Compares MTX Dosing, Finds No Significant Difference· Mar 6, 2025
2022
- Pivotal publicationAdalimumab: SEAVUE Study Compares to Ustekinumab in Crohn's Disease· Jan 1, 2022
- Pivotal publicationAdalimumab: Olokizumab Compared in Rheumatoid Arthritis Trial· Jan 1, 2022
2019
- Pivotal publicationAdalimumab Compared to Vedolizumab for Moderate-to-Severe Ulcerative Colitis· Jan 1, 2019
2018
- Pivotal publicationAdalimumab Study Published on Non-Radiographic Axial Spondyloarthritis· Jan 1, 2018
- Pivotal publicationAdalimumab Efficacy and Safety vs. Methotrexate in Pediatric Psoriasis Published· Jan 1, 2018
Upcoming & expected milestones
Trial started· ClinicalTrials.gov
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
Primary completion· ClinicalTrials.gov
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Ar
Primary completion· ClinicalTrials.gov
Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease
Primary completion· ClinicalTrials.gov
"Comparison of the Efficacy and Safety of Adalimumab to That of Tocilizumab in Severe Uveitis of Behçet's Disease"
Trial started· ClinicalTrials.gov
Apremilast and Adalimumab in Psoriatic Arthritis Patients
Primary completion· ClinicalTrials.gov
Apremilast and Adalimumab in Psoriatic Arthritis Patients
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet's Uveitis
Trial started· ClinicalTrials.gov
Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis
Primary completion· ClinicalTrials.gov
Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
Primary completion· ClinicalTrials.gov
Study to Evaluate the Safety and Efficacy of Adalimumab in MPS I, II, and VI
Primary completion· ClinicalTrials.gov
Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt
Primary completion· ClinicalTrials.gov
A Study of LAD191 in Adults With Hidradenitis Suppurativa
Primary completion· ClinicalTrials.gov
A Study of LAD191 in Adults With Hidradenitis Suppurativa
Primary completion· ClinicalTrials.gov
Subconjunctival Humira for Boston Keratoprosthesis
Primary completion· ClinicalTrials.gov
Treatment FOr Corticosteroid Dependent UveitiS
Primary completion· ClinicalTrials.gov
A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
Primary completion· ClinicalTrials.gov
Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis
Primary completion· ClinicalTrials.gov
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
Primary completion· ClinicalTrials.gov
PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
Primary completion· ClinicalTrials.gov
An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis
Primary completion· ClinicalTrials.gov
Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis
Primary completion· ClinicalTrials.gov
A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participant
Primary completion· ClinicalTrials.gov
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Primary completion· ClinicalTrials.gov
Phase IIb Clinical Study to Assess the Efficacy and Safety of GenSci120 Injection in Patients With Moderately to Severely Active RA Who Have
Primary completion· ClinicalTrials.gov
Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activi
Primary completion· ClinicalTrials.gov
Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis
Primary completion· ClinicalTrials.gov
Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission
Primary completion· ClinicalTrials.gov
Effect of Proactive Therapeutic Drug Monitoring on Maintenance of Sustained Disease Control in Adults With Rheumatoid Arthritis on a Subcuta
Primary completion· ClinicalTrials.gov
Immunoclassification of Psoriasis: a Strategy for Precision Medicine
Primary completion· ClinicalTrials.gov
Fluorescence Imaging of Adalimumab-680LT and Risankizumab-800CW in Inflammatory Bowel Disease
Primary completion· ClinicalTrials.gov
The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis
Primary completion· ClinicalTrials.gov
Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis
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
Effects of TNF Blockade on Human BPH/LUTS
Primary completion· ClinicalTrials.gov
A Clinical Trail of Adalimumab in Treating Chinese Children With Severe Plaque Psoriasis
Primary completion· ClinicalTrials.gov
Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis
Primary completion· ClinicalTrials.gov
CHronic Nonbacterial Osteomyelitis International Registry
Primary completion· ClinicalTrials.gov
TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response
Primary completion· ClinicalTrials.gov
An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Pers
Primary completion· ClinicalTrials.gov
Post - Marketing Case Registration Study on the Safety and Efficacy of Adalimumab Solution for Injection in Chinese Pediatric Patients With
Primary completion· ClinicalTrials.gov
An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Pers
Primary completion· ClinicalTrials.gov
An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Pers
Primary completion· ClinicalTrials.gov
Biologics in Folliculitis Decalvans : an Adaptative Trial Research
Primary completion· ClinicalTrials.gov
Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis
Primary completion· ClinicalTrials.gov
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
Primary completion· ClinicalTrials.gov
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
Primary completion· ClinicalTrials.gov
Swiss Dermatology Network of Targeted Therapies (SDNTT)
Past events
2026
Trial registered· ClinicalTrials.gov
Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease
Label revision· FDA
WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitaliza
Label revision· FDA
WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitaliza
Label revision· FDA
WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitaliza
Primary completion· ClinicalTrials.gov
A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on
Trial started· ClinicalTrials.gov
An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Pers
Primary completion· ClinicalTrials.gov
Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children With Moderate to Severe Plaque Psoriasis
Trial started· ClinicalTrials.gov
An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Pers
Results posted· ClinicalTrials.gov
Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy
Results posted· ClinicalTrials.gov
An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
Trial started· ClinicalTrials.gov
Subconjunctival Humira for Boston Keratoprosthesis
Trial started· ClinicalTrials.gov
Post - Marketing Case Registration Study on the Safety and Efficacy of Adalimumab Solution for Injection in Chinese Pediatric Patients With
Trial started· ClinicalTrials.gov
A Clinical Trail of Adalimumab in Treating Chinese Children With Severe Plaque Psoriasis
Trial started· ClinicalTrials.gov
An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Pers
Label revision· FDA
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and P
Trial registered· ClinicalTrials.gov
Post - Marketing Case Registration Study on the Safety and Efficacy of Adalimumab Solution for Injection in Chinese Pediatric Patients With
Trial started· ClinicalTrials.gov
Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis
FDA approval (supplemental)· FDA
Sponsor: SAMSUNG BIOEPIS CO LTD. Class: Manufacturing (CMC).
Trial registered· ClinicalTrials.gov
A Clinical Trail of Adalimumab in Treating Chinese Children With Severe Plaque Psoriasis
Primary completion· ClinicalTrials.gov
Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease
Trial registered· ClinicalTrials.gov
TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response
Trial started· ClinicalTrials.gov
Biologics in Folliculitis Decalvans : an Adaptative Trial Research
Primary completion· ClinicalTrials.gov
De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease
Primary completion· ClinicalTrials.gov
Fluorescence Imaging of IBD and RA Using Adalimumab-800CW
Trial registered· ClinicalTrials.gov
Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt
Trial registered· ClinicalTrials.gov
Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission
Trial started· ClinicalTrials.gov
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
Label revision· FDA
WARNING: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning . SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitaliz
Trial started· ClinicalTrials.gov
Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt
Trial started· ClinicalTrials.gov
TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response
Trial started· ClinicalTrials.gov
Phase IIb Clinical Study to Assess the Efficacy and Safety of GenSci120 Injection in Patients With Moderately to Severely Active RA Who Have
Primary completion· ClinicalTrials.gov
To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects
Trial registered· ClinicalTrials.gov
Phase IIb Clinical Study to Assess the Efficacy and Safety of GenSci120 Injection in Patients With Moderately to Severely Active RA Who Have
Trial registered· ClinicalTrials.gov
Apremilast and Adalimumab in Psoriatic Arthritis Patients
Trial registered· ClinicalTrials.gov
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
Primary completion· ClinicalTrials.gov
Evaluation of IL 12B Genetic Polymorphism (rs3213094)
Trial registered· ClinicalTrials.gov
Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases
Trial started· ClinicalTrials.gov
Fluorescence Imaging of Adalimumab-680LT and Risankizumab-800CW in Inflammatory Bowel Disease
Primary completion· ClinicalTrials.gov
Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
Results posted· ClinicalTrials.gov
A Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adul
Trial started· ClinicalTrials.gov
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
2025
Primary completion· ClinicalTrials.gov
Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events
Primary completion· ClinicalTrials.gov
Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: FRESENIUS KABI USA.
Label revision· FDA
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including SIMLANDI, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and
Trial registered· ClinicalTrials.gov
Biologics in Folliculitis Decalvans : an Adaptative Trial Research
Trial registered· ClinicalTrials.gov
Fluorescence Imaging of Adalimumab-680LT and Risankizumab-800CW in Inflammatory Bowel Disease
Primary completion· ClinicalTrials.gov
Personalized Therapies in Inflammatory Complex Disease
Primary completion· ClinicalTrials.gov
A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects
Results posted· ClinicalTrials.gov
Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial
Primary completion· ClinicalTrials.gov
Personalized Therapies in Inflammatory Complex Disease
FDA approval (supplemental)· FDA
Sponsor: COHERUS BIOSCIENCES INC.
FDA approval (supplemental)· FDA
Sponsor: ALVOTECH USA INC. Class: Labeling.
Primary completion· ClinicalTrials.gov
Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis
FDA approval (supplemental)· FDA
Sponsor: SAMSUNG BIOEPIS CO LTD. Class: Manufacturing (CMC).
FDA approval (supplemental)· FDA
Sponsor: ALVOTECH USA INC.
Results posted· ClinicalTrials.gov
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
FDA approval (supplemental)· FDA
Sponsor: CELLTRION.
FDA approval (supplemental)· FDA
Sponsor: AMGEN INC.
FDA approval (supplemental)· FDA
Sponsor: BOEHRINGER INGELHEIM. Class: Bioequivalence.
FDA approval (supplemental)· FDA
Sponsor: SANDOZ INC.
Recall· FDA
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, R
Trial started· ClinicalTrials.gov
A Study of LAD191 in Adults With Hidradenitis Suppurativa
Trial started· ClinicalTrials.gov
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Trial registered· ClinicalTrials.gov
A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects
FDA approval (supplemental)· FDA
Sponsor: AMGEN INC. Class: Labeling.
Trial registered· ClinicalTrials.gov
A Study of LAD191 in Adults With Hidradenitis Suppurativa
Trial registered· ClinicalTrials.gov
A Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adul
Trial registered· ClinicalTrials.gov
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Trial registered· ClinicalTrials.gov
Evaluation of IL 12B Genetic Polymorphism (rs3213094)
Trial registered· ClinicalTrials.gov
Characteristics of Ankylosing Spondylitis Associated Uveitis
Trial started· ClinicalTrials.gov
An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis
Trial started· ClinicalTrials.gov
Evaluation of IL 12B Genetic Polymorphism (rs3213094)
Primary completion· ClinicalTrials.gov
Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases
Primary completion· ClinicalTrials.gov
The Evaluation of Injection Site Pain and Adherence in Patients Switching From a Low To High Concentration Adalimumab (AVT-02) Across Multip
FDA approval (supplemental)· FDA
Sponsor: SANDOZ INC. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Labeling.
Primary completion· ClinicalTrials.gov
Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
Trial registered· ClinicalTrials.gov
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
Primary completion· ClinicalTrials.gov
The Clinical Efficacy of Immunomodulators in RA Patients
Trial started· ClinicalTrials.gov
Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis
FDA approval (supplemental)· FDA
Sponsor: SAMSUNG BIOEPIS CO LTD. Class: Labeling.
Trial started· ClinicalTrials.gov
Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission
Trial started· ClinicalTrials.gov
The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis
Trial registered· ClinicalTrials.gov
The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis
Results posted· ClinicalTrials.gov
A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juven
Primary completion· ClinicalTrials.gov
Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients
Trial registered· ClinicalTrials.gov
An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Pers
FDA approval (supplemental)· FDA
FDA approved supplemental application for Adalimumab (adalimumab-aaty) — Supplement (BLA 761219 S-9)
Sponsor: CELLTRION. Class: Supplement.
FDA approval (supplemental)· FDA
Sponsor: CELLTRION. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: SAMSUNG BIOEPIS CO LTD. Class: Supplement.
FDA approval (supplemental)· FDA
Sponsor: SAMSUNG BIOEPIS CO LTD. Class: Supplement.
FDA approval (supplemental)· FDA
Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: AMGEN INC. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: SANDOZ INC. Class: Supplement.
Results posted· ClinicalTrials.gov
Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
Primary completion· ClinicalTrials.gov
A Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adul
Primary completion· ClinicalTrials.gov
A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Init
Trial registered· ClinicalTrials.gov
An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis
Results posted· ClinicalTrials.gov
AScalate: Treat-to-target in Axial Spondyloarthritis
Trial registered· ClinicalTrials.gov
Subconjunctival Humira for Boston Keratoprosthesis
Primary completion· ClinicalTrials.gov
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
FDA approval (supplemental)· FDA
Sponsor: ALVOTECH USA INC. Class: Manufacturing (CMC).
FDA approval (supplemental)· FDA
Sponsor: ALVOTECH USA INC. Class: Manufacturing (CMC).
FDA approval (supplemental)· FDA
Sponsor: AMGEN INC. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: CELLTRION.
Primary completion· ClinicalTrials.gov
Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira®
Primary completion· ClinicalTrials.gov
Januse Kinase Inhibition With Filgotinib to Silence Autoreactive B Cells in Rheumatoid Arthritis
Results posted· ClinicalTrials.gov
Adalimumab in JIA-associated Uveitis Stopping Trial
Trial started· ClinicalTrials.gov
A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects
Results posted· ClinicalTrials.gov
Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan
Primary completion· ClinicalTrials.gov
IKBKB Gene Polymorphism (Single Nucleotide Polymorphism) (SNP) in Psoriatic and Psoriatic Arthritis Patients
Trial started· ClinicalTrials.gov
Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis
Primary completion· ClinicalTrials.gov
A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS)
Trial registered· ClinicalTrials.gov
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
Trial registered· ClinicalTrials.gov
Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis
FDA approval (supplemental)· FDA
Sponsor: ALVOTECH USA INC. Class: Manufacturing (CMC).
Trial started· ClinicalTrials.gov
A Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adul
FDA approval (supplemental)· FDA
Sponsor: MYLAN PHARMS INC.
Results posted· ClinicalTrials.gov
The Anti-Freaze-F Study- "Anti-TNF for Treatment of Frozen Shoulder - a Feasibility Study"
Primary completion· ClinicalTrials.gov
Adalimumab in JIA-associated Uveitis Stopping Trial
Primary completion· ClinicalTrials.gov
TDM Guided Early Optimization of ADAL in Crohn's Disease
Trial started· ClinicalTrials.gov
Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease
2024
Primary completion· ClinicalTrials.gov
The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients
Primary completion· ClinicalTrials.gov
Identification of Predictive Biomarkers for Response to Biologic Therapies and Tofacitinib in Inflammatory Bowel Disease
Primary completion· ClinicalTrials.gov
Adalimumab Drug Optimisation in Rheumatoid Arthritis Using Therapeutic Drug Monitoring
Primary completion· ClinicalTrials.gov
Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)
Primary completion· ClinicalTrials.gov
Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease
FDA approval (supplemental)· FDA
Sponsor: CELLTRION. Class: Labeling.
Trial registered· ClinicalTrials.gov
Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease
FDA approval (supplemental)· FDA
Sponsor: FRESENIUS KABI USA. Class: Labeling.
Trial registered· ClinicalTrials.gov
IKBKB Gene Polymorphism (Single Nucleotide Polymorphism) (SNP) in Psoriatic and Psoriatic Arthritis Patients
Primary completion· ClinicalTrials.gov
A Study of Adalimumab in Acute Vogt-Koyanagi-Harada Disease
Trial started· ClinicalTrials.gov
IKBKB Gene Polymorphism (Single Nucleotide Polymorphism) (SNP) in Psoriatic and Psoriatic Arthritis Patients
Primary completion· ClinicalTrials.gov
Experimental Medicine Studies of the Brain in Patients With Rheumatoid Arthritis REALISE
Trial started· ClinicalTrials.gov
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
Trial started· ClinicalTrials.gov
Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activi
Primary completion· ClinicalTrials.gov
Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial
Primary completion· ClinicalTrials.gov
REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST)
Results posted· ClinicalTrials.gov
Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease
Results posted· ClinicalTrials.gov
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Primary completion· ClinicalTrials.gov
Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis
Primary completion· ClinicalTrials.gov
Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis
Label revision· FDA
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including IDACIO are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Pre
Results posted· ClinicalTrials.gov
A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, a
Trial registered· ClinicalTrials.gov
Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children With Moderate to Severe Plaque Psoriasis
Results posted· ClinicalTrials.gov
Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity
Primary completion· ClinicalTrials.gov
Efficacy, Safety and Costs of Methotrexate, Adalimumab, or Their Combination in Non-infectious Non-anterior Uveitis
Trial registered· ClinicalTrials.gov
Treatment Persistence of Biologics in Patients with PsA in Japan; Retrospective Cohort Study Using a Claims Database
FDA approval (supplemental)· FDA
Sponsor: ALVOTECH USA INC. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: ALVOTECH USA INC. Class: Labeling.
Trial started· ClinicalTrials.gov
Effect of Proactive Therapeutic Drug Monitoring on Maintenance of Sustained Disease Control in Adults With Rheumatoid Arthritis on a Subcuta
FDA approval (supplemental)· FDA
Sponsor: AMGEN INC. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: CELLTRION. Class: Labeling.
Results posted· ClinicalTrials.gov
A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Ante
Trial started· ClinicalTrials.gov
Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children With Moderate to Severe Plaque Psoriasis
Trial started· ClinicalTrials.gov
Fluorescence Imaging of IBD and RA Using Adalimumab-800CW
Trial registered· ClinicalTrials.gov
Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
Trial started· ClinicalTrials.gov
Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
Trial registered· ClinicalTrials.gov
A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on
Results posted· ClinicalTrials.gov
IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA
Trial started· ClinicalTrials.gov
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Ar
Primary completion· ClinicalTrials.gov
Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis
Primary completion· ClinicalTrials.gov
Therapeutic Monitoring of Infliximab and Adalimumab
Trial started· ClinicalTrials.gov
A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on
FDA approval (supplemental)· FDA
Sponsor: SAMSUNG BIOEPIS CO LTD.
Results posted· ClinicalTrials.gov
Repurposing Anti-TNF for Treating Dupuytren's Disease
FDA approval (supplemental)· FDA
Sponsor: ALVOTECH USA INC. Class: Manufacturing (CMC).
FDA approval (supplemental)· FDA
Sponsor: SANDOZ INC. Class: Labeling.
Primary completion· ClinicalTrials.gov
A Study to Assess Change in Disease Activity and Adverse Events of Adalimumab in Chinese Participants Requiring High Dose Corticosteroids fo
Trial registered· ClinicalTrials.gov
Effect of Proactive Therapeutic Drug Monitoring on Maintenance of Sustained Disease Control in Adults With Rheumatoid Arthritis on a Subcuta
FDA approval (supplemental)· FDA
Sponsor: FRESENIUS KABI USA. Class: Labeling.
Trial started· ClinicalTrials.gov
Diabetes Islet Preservation Immune Treatment
Primary completion· ClinicalTrials.gov
Diabetes Islet Preservation Immune Treatment
Trial started· ClinicalTrials.gov
Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients
Primary completion· ClinicalTrials.gov
Control Crohn Safe Trial
FDA approval (supplemental)· FDA
Sponsor: ALVOTECH USA INC. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.
Trial registered· ClinicalTrials.gov
Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis
Trial started· ClinicalTrials.gov
A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
Trial registered· ClinicalTrials.gov
Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients
Trial started· ClinicalTrials.gov
Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis
FDA approval (supplemental)· FDA
Sponsor: SANDOZ INC. Class: Bioequivalence.
Primary completion· ClinicalTrials.gov
Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
Trial started· ClinicalTrials.gov
Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease
Primary completion· ClinicalTrials.gov
Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
Trial registered· ClinicalTrials.gov
Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)
Trial started· ClinicalTrials.gov
Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis
Trial started· ClinicalTrials.gov
A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participant
Trial started· ClinicalTrials.gov
A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS)
Trial registered· ClinicalTrials.gov
Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis
Trial started· ClinicalTrials.gov
Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis
Trial registered· ClinicalTrials.gov
A Clinical Study With Adalimumab Biosimilar
Trial started· ClinicalTrials.gov
Treatment FOr Corticosteroid Dependent UveitiS
Trial started· ClinicalTrials.gov
Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases
FDA approval· FDA
Sponsor: ALVOTECH USA INC.
Trial registered· ClinicalTrials.gov
Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis
Primary completion· ClinicalTrials.gov
A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juven
Trial registered· ClinicalTrials.gov
Treatment FOr Corticosteroid Dependent UveitiS
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.