An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00264550
• Date of registration: 11/12/2005
• Prospective Registration: No
• Primary sponsor: Centocor, Inc.
• Public title: An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy GO-FORWARD
• Scientific title: A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Subjects With ActiveRheumatoid Arthritis Despite Methotrexate Therapy
• Date of first enrolment: December 2005
• Target sample size: 444
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00264550
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Brazil, Canada, Chile, Germany, Hungary, India, Korea, Republic of, Mexico, New Zealand, Poland, Taiwan, Turkey, United States

Contacts

• Name: Centocor, Inc. Clinical Trial
• Affiliation: Centocor, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria
of the ACR) for at least 3 months prior to screening

- Must have been treated with and tolerated methotrexate (MTX) at a dose of at least 15
mg/week for at least 3 months prior to screening, and have a MTX dose of >=15 mg/week
and <=25 mg/week and stable for at least 4 weeks prior to screening

- Have active RA as defined by persistent disease activity with at least 4 swollen and 4
tender joints, at the time of screening and baseline, and at least 2 of the following
4 criteria: a)C-reactive protein (CRP) >=1.5 mg/dL at screening or erythrocyte
sedimentation rate (ESR) by Westergren method of >= 28 mm in the first hour at
screening or baseline, b)Morning stiffness of >= 30 minutes at screening and baseline,
c)Bone erosion by x-ray and/or magnetic resonance imaging (MRI) prior to first
administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP)
antibody-positive or rheumatoid factor (RF) positive at screening

- If using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of
prednisone/day for at least 2 weeks prior to first administration of study agent

- Are considered eligible according to specified tuberculosis (TB) screening criteria

Exclusion Criteria:

- Have inflammatory diseases other than RA that might confound the evaluation of the
benefit of golimumab therapy

- Have had treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic
immunosuppressives other than MTX, during the 4 weeks prior to the first
administration of study agent

- Have had prior treatment with biologic anti-tumor necrosis factor (TNF) drugs
(infliximab, etanercept, adalimumab)

- Have had history of, or ongoing, chronic or recurrent infectious disease.

- Have serious infection within 2 months prior to first administration of study agent

- Have a history of latent or active granulomatous infection, including TB,
histoplasmosis, or coccidioidomycosis, prior to screening



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Methotrexate

Drug: Golimumab 100 mg

Drug: Golimumab 50 mg

Drug: Placebo capsules

Drug: Placebo injection

Primary Outcome(s)

Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14 [Time Frame: Week 14]

Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24 [Time Frame: Baseline (Week 0) and Week 24]

Secondary Outcome(s)

Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24 [Time Frame: Baseline (Week 0) and Week 24]

Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24 [Time Frame: Week 24]

Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14 [Time Frame: Week 14]

Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14 [Time Frame: Baseline (Week 0) and Week 14]

Secondary ID(s)

2004-003296-36

C0524T06

CR006343

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Schering-Plough

Results

• Results available: Yes
• Date Posted: 21/03/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00264550