GENMAB LAUNCHES PHASE II RHEUMATOID ARTHRITIS STUDY
Genmab announced that it has initiated a Phase II study with HuMax-CD20 to treat patients with active rheumatoid arthritis who have failed one treatment with one or more disease modifying antirheumatic drugs.
Genmab has completed treatment of 33 patients in a Phase I/II dose escalation trial and expanded the study into a Phase II trial, which will include 200 additional patients.
In the Phase II trial, a total of 200 patients will be randomized into four treatment groups. In each group, 50 patients will receive two infusions of either 300, 700, or 1000 mg doses of HuMax-CD20 or placebo. The doses will be given two weeks apart. Patients receiving a stable dose of methotrexate between 7.5 and 25 mg per week at the time of screening will continue with it. Patients will be followed for 24 weeks to evaluate safety and efficacy and then every 12 weeks until B-cell counts return to baseline levels.