Rheumatoid Arthritis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGHuMax-CD4
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.
DRUGPlacebo
Placebo was administered as a subcutaneous infusion twice (BID) with 2 weeks interval followed by administration every 4 weeks up to Week 22.
DRUGHumax-CD4
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.
Sponsors
Genmab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of rheumatoid arthritis according to the American College of Rheumatology 1987 revised criteria (ACR) of at least 6 months duration. * Active disease at the time of screening. * Failure to tolerate MTX, or lack of efficacy after a minimum of 6 months treatment with MTX.
Exclusion criteria
* Active autoimmune disease requiring therapy (other than rheumatoid arthritis and secondary Sjögren's disease). * Syndromes such as Fibromyalgia which require chronic pain treatment. * Most past or current cancers. * Chronic or current infectious disease such as, but not limited to, chronic renal infection, chronic chest, nasal or throat infections, tuberculosis, hepatitis B and C. * History of infected joint prosthesis within 5 years. * Most active medical conditions such as heart disease, kidney disease, liver disease, blood diseases, hormonal disturbances, lung disease, psychiatric disease. * Drug or alcohol abuse. * Pregnant or breast-feeding women may not participate. Women of childbearing potential must use either contraceptive pills or an intra-uterine device for the entire study period. Note: Other protocol defined Inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (AEs) | Day 1 up to end of study (Week 26) |
| Change from Baseline in C-Reactive Protein (CRP) | Baseline up to Week 26 |
| Change from Baseline in Erythrocyte Sedimentation Rate (ESR) | Baseline up to Week 26 |
| Number of Participants with American College of Rheumatology (ACR) 20 Response | At Week 14 and Week 18 |
| Change from Baseline in Disease Activity Score (DAS) | Baseline up to Week 26 |
| Change from Baseline in SFP-36 questionnaire at Week 10 and 26 | Baseline, Week 10 and Week 26 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Clinically Significant Laboratory Abnormalities | Up to 26 weeks |
| Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres | Up to 26 weeks |
Countries
Canada, United States
Outcome results
None listed