A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Genentech, Inc.
Study ID
NCT00282308
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab was supplied in single-use vials.
  • Methotrexate — DRUG
  • Methylprednisone — DRUG
    Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
  • C. albicans — BIOLOGICAL
    Patients received an intradermal injection of C. albicans (0.1 mL) on the volar surface of the forearm.
  • Tetanus toxoid adsorbed booster vaccine — BIOLOGICAL
    Patients received an intramuscular injection of the tetanus toxoid adsorbed booster vaccine (1 mg in 0.5 mL) in the deltoid muscle.
  • 23-valent pneumococcal polysaccharide vaccine — BIOLOGICAL
    Patients received an intramuscular injection of the 23-valent pneumococcal polysaccharide vaccine (0.5 mL) in the deltoid muscle.
  • Keyhole limpet hemocyanin — BIOLOGICAL
    Patients received a subcutaneous injection of keyhole limpet hemocyanin (1 mg)

Study Details

This was a Phase II, randomized, open-label, multicenter study designed to evaluate the immune response to vaccines after administration of 1000 mg of rituximab in subjects with active rheumatoid arthritis (RA) who were receiving background methotrexate (MTX).

Key Dates

Start date
Jan 23, 2006
Status verified
Jul 2017
Primary completion
Jan 31, 2008
Completion
May 28, 2012

Study Design

Enrollment
103 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab + methotrexate (Group A)
    Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
  • Active Comparator: Methotrexate (Group B)
    Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.

Primary Outcome Measure

Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster Vaccine [ Time Frame: Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B ]

Locations (34)

FacilityCityStateZIPSite coordinators
Univ of Alabama at BirminghamBirminghamAlabama35294-
Arizona Arthritis & Rheumatology Research, PllcParadise ValleyArizona85253-
Sun Valley Arthritis CenterPeoriaArizona85381-
Desert Medical AdvancesPalm DesertCalifornia92260-
Inland Rheumatology; Clinical Trials, Inc.UplandCalifornia91786-
Arthritis Associates of South FloridaDelray BeachFlorida33484-
The Arthritis CenterPalm HarborFlorida34684-
Center For Arthritis; Research DeptSouth MiamiFlorida33143-
Intermountain OrthopaedicsBoiseIdaho83702-
Northwestern UniversityChicagoIllinois60611-
Univ of ChicagoChicagoIllinois60637-
Evanston Northwestern HealthcareEvanstonIllinois--
Springfield ClinicSpringfieldIllinois62703-
Kentuckiana Center For Better Bone & Joint HealthxLouisvilleKentucky40202-
Clinical Research NetworkSlidellLouisiana70458-
Johns Hopkins University; RheumatologyBaltimoreMaryland21224-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Borgess Research InstituteKalamazooMichigan49048-
Rheumatology, P.C.; Medical Arts BuildingKalamazooMichigan49009-
Justus Fiechtner MD - PPLansingMichigan48910-
Center for Rheumatology, State Uni. of New YorkAlbanyNew York12206-
Aair Research CenterRochesterNew York14618-
University of Rochester - Strong Memorial HospitalRochesterNew York14642-
Physicians East PaGreenvilleNorth Carolina27834-
Health Research of Oklahoma, LlcOklahoma CityOklahoma73103-
Oregon Health Sciences UniPortlandOregon97239-
Altoona Arthritis & Osteo CenterDuncansvillePennsylvania16635-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Medical University of S. CarolinaCharlestonSouth Carolina29425-
Rheumatology AssociatesCharlestonSouth Carolina29407-
Arthritis AssociatesHixsonTennessee37343-
Arthritis Care & Diagnostic CenterDallasTexas75231-4406-
Arthritis Clinic of Northern VirginiaArlingtonVirginia22205-
Arthritis Northwest, SpokaneSpokaneWashington99204-

Find similar trials in Birmingham, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Univ of Alabama at Birmingham· Birmingham, ALArizona Arthritis & Rheumatology Research, Pllc· Paradise Valley, AZSun Valley Arthritis Center· Peoria, AZDesert Medical Advances· Palm Desert, CAInland Rheumatology; Clinical Trials, Inc.· Upland, CAArthritis Associates of South Florida· Delray Beach, FL

Related Studies