The purpose of this study is to determine whether HuMax-CD4 is effective in the treatment of active RA in participants who have failed treatment with MTX and at least one TNF-alpha blocking agent.
This is a multi-center, double-blind, placebo-controlled, parallel-group, randomized trial of HuMax-CD4 in the treatment of participants with active RA who have failed treatment with MTX and at least one TNF-alpha blocking agent. Participants are randomized to receive one of two doses of HuMax-CD4 or placebo. The drug will be administered as a subcutaneous infusion (given just under the skin), more often in the beginning and then followed by a maintenance dose. There is a 4 week follow up period, and the final evaluation of the clinical endpoints takes place 26 weeks after treatment start. The trial lasts about 28 weeks in all.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
HuMax-CD4 80 mg was administered as a subcutaneous infusion BID with 2 weeks interval followed by administration every 4 weeks up to Week 22.
Placebo was administered as a subcutaneous infusion twice (BID) with 2 weeks interval followed by administration every 4 weeks up to Week 22.
HuMax-CD4 160 mg was administered as a subcutaneous infusion BID with 2 weeks interval followed by administration every 4 weeks up to Week 22.
Number of Participants with American College of Rheumatology (ACR) 20 Response
Time frame: At Week 14 and Week 18
Change from Baseline in Disease Activity Score (DAS)
Time frame: Baseline up to Week 26
Change from Baseline in SFP-36 questionnaire at Week 10 and 26
Time frame: Baseline, Week 10 and Week 26
Change from Baseline in C-Reactive Protein (CRP)
Time frame: Baseline up to Week 26
Change from Baseline in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline up to Week 26
Number of Participants with Adverse Events (AEs)
Time frame: Day 1 up to end of study (Week 26)
Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
Time frame: Up to 26 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Up to 26 weeks
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