A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00264537
• Date of registration: 11/12/2005
• Prospective Registration: No
• Primary sponsor: Centocor, Inc.
• Public title: A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive
• Scientific title: A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid Arthritis
• Date of first enrolment: December 2005
• Target sample size: 637
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00264537
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Hungary, India, Korea, Republic of, Malaysia, Mexico, New Zealand, Philippines, Poland, Russian Federation, Singapore, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, 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 first administration of study agent

- Are methotrexate (MTX)-naïve (ie, have not received more than 3 weekly doses of MTX
for RA at any time)

- 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 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.

Exclusion Criteria:

- Can not have inflammatory diseases other than RA that might confound the evaluation of
the benefit of golimumab therapy

- No treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic
immunosuppressives during the 4 weeks prior to the first administration of study agent

- No prior treatment with biologic anti-TNF drugs (infliximab, etanercept, adalimumab)

- No history of, or ongoing, chronic or recurrent infectious disease

- No serious infection within 2 months prior to first administration of study agent.



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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Placebo injections

Biological: Golimumab 50 mg injections

Drug: Methotrexate capsules

Biological: Golimumab 100 mg injections

Drug: Placebo capsules

Primary Outcome(s)

Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 [Time Frame: Week 24]

Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 [Time Frame: Baseline and Week 52]

Secondary Outcome(s)

Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 in Patients With Abnormal C-reactive Protein (CRP Greater Than 1.0 mg/dL) at Baseline [Time Frame: Baseline and Week 52]

Number of Patients With Abnormal Baseline C-reactive Protein (CRP) Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 [Time Frame: Week 24]

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

Secondary ID(s)

C0524T05

CR006331

GO-BEFORE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Schering-Plough

Results

• Results available: Yes
• Date Posted: 13/07/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00264537