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Sponsors and Collaborators: |
Centocor, Inc. Schering-Plough |
Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00264550 |
The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have active rheumatoid arthritis despite treatment with methotrexate
Condition | Intervention | Phase |
Rheumatoid Arthritis |
Drug: placebo; methotrexate ; golimumab Biological: golimumab; placebo Biological: Golimumab |
Phase III |
MedlinePlus related topics: | Rheumatoid Arthritis |
ChemIDplus related topics: | Methotrexate Golimumab |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official 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 |
Enrollment: | 444 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | May 2012 |
Arms | Assigned Interventions |
001: Placebo Comparator |
Drug: placebo; methotrexate ; golimumab
sc injections every 4 wks through Week 20 (or Week 16 if early escape); methotrexate - 15-25mg every 4 wks up to 5 yrs; golimumab - If early escape, 50mg sc injs every 4 wks beginning wk 16 up to 5 yrs; golimumab - 50 mg sc injections every 4 wks beginning wk 24 up to 5 yrs (unless eary escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg
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002: Experimental |
Biological: golimumab; placebo
100 mg sc injections every 4 wks from wk 0 up to 5 yrs; placebo - 7-10 capsules weekly during blinded period (or wk 16 if early escape); methotrexate - If early escape, 15-25mg weekly beginning wk 16 up to 5 yrs; methotrexate - Dr's discretion, adjust weekly dose after unblinding
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003: Experimental |
Biological: Golimumab
50 mg every 4 wks from wk 0 up to 5 yrs (unless early escape at wk 16); Methotrexate - 15-25 mg for up to 5 years; Golimumab - If early escape,100 mg sc injs every 4 wks beginning wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjust from 50 to100mg
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004: Experimental |
Biological: Golimumab
100 mg sc injections every 4 wks from wk 0 up to 5 yrs; Methotrexate - 15-25 mg weekly from wk 0 up to 5 yrs
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Golimumab is a fully human protein (antibody) which binds to tumor necrosis factor (TNFα). TNFα is increased in patients with rheumatoid arthritis (RA), and plays a major role in causing the joint pain, swelling, and damage from RA. Other marketed drugs that target TNFα (anti-TNFα drugs) have been shown to be effective in reducing the symptoms, signs, and joint damage of RA, but have limitations with respect to safety and ease of use. This is a randomized, double-blind, placebo-controlled trial of the efficacy and safety of a new anti-TNFα drug, golimumab, at 2 doses, injected under the skin every 4 weeks, alone or in combination with methotrexate, compared with methotrexate alone, in subjects with active RA despite treatment with methotrexate. The study hypothesis is that golimumab, alone or in combination with methotrexate, will be more effective in treatment of RA than methotrexate alone, as measured by the American College of Rheumatology (ACR) response criteria and change from baseline in the Health Assessment Questionnaire (HAQ), without causing unacceptable significant adverse effects. The ACR response criteria were designed to determine the percentage of subjects who have achieved a certain level of improvement in their signs and symptoms of RA. The HAQ is a series of questions that measure a subject's impairment in physical function caused by RA. Other secondary measures of effectiveness include the van der Heijde Modified Sharp (vdH-S) score, which is a measurement of the amount of joint damage in a subject as seen by x-ray.
Golimumab 50 mg or 100 mg or placebo injections under the skin every 4 weeks through week 20. Methotrexate or placebo capsules will be given in addition. At Week 24, all subjects receive golimumab 50mg or 100mg injections, and golimumab continues for all groups for about 4 and a half more years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Centocor Inc. ( Director of Clinical Research ) |
Study ID Numbers: | CR006343, C0524T06, GO-FORWARD |
First Received: | December 11, 2005 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00264550 |
Health Authority: | United States: Food and Drug Administration |
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