Trial With HuMax-CD4 in Patients With Rheumatoid Arthritis Failing Treatment With Methotrexate and a TNF-alpha Blocker

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether HuMax-CD4 is effective in the treatment of active rheumatoid arthritis in patients who have failed treatment with Methotrexate and at least one TNF-alpha blocking agent.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emergent Product Development Seattle LLC
• Treatments: Antibodies, Monoclonal; Methotrexate; Zanolimumab

Criteria

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.

• Unable to tolerate Methotrexate, or lack of efficacy after a minimum of 6 months treatment.

• Failure to tolerate treatment with either Enbrel or Remicade, or lack of efficacy after at least 3 months treatment with one of these agents.

Exclusion Criteria:

• Active autoimmune disease requiring therapy (other than rheumatoid arthritis and secondary Sjögren's disease).

• The use of certain treatments or drugs for treatment of rheumatoid arthritis within 4 weeks of participation in the trial.

• 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.