Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403

• Status: Terminated
• Trial end date: 2013-03-19
• Target enrollment: 0
• Participant gender: All

Summary

A 3-year open-label trial for patients who previously participated in Trial Hx-CD20-403 and who fulfill the eligibility criteria for this trial (GEN413) . Th e primary purpose of the trial is to evaluate the long-term effectiveness of repeated courses ( a maximum of 9 treatment courses) of ofatumumab in RA patients who previously received ofatumumab or placebo in Trial Hx-CD20-403.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal; Ofatumumab

Criteria

Inclusion Criteria:

• Previously received ofatumumab or placebo in Trial Hx-CD20-403.

• Patients on methotrexate therapy (7.5 - 25 mg/week, p.o., i.m., and/or s.c.).

• Oral corticosteroids therapy (≤ 10 mg/day prednisolone or equivalent).

• Active disease at the time of screening as defined by:

• 3 swollen joints (of 28 joints assessed) and ≥ 3 tender joints (of 28 joints assessed), DAS28≥3.2 (based on ESR)

Exclusion Criteria:

• Use of DMARDs other than methotrexate or exposure to other cell depleting therapy, including investigational compounds < 6 months prior to Visit 2 A.

• Patients who have received treatment with any non-marketed drug substance within 4 weeks prior to Visit 1 (screening).

• Breast feeding women or women with a positive pregnancy test at Visit 1 (screening).

• Received anti-cancer therapy, corticosteroids (intra-articular, i.m., or i.v.), or live/attenuated vaccinations, or exposure to cyclophosphamide, nitrogen mustard, chlorambucil or other alkylating agents < 5 years prior to screening.

• Past or current malignancy, except for Cervical carcinoma Stage 1B or less, Non-invasive basal cell and squamous cell skin carcinoma, Malignant melanoma with a complete response of a duration of > 10 years, or other cancer diagnoses with a complete response of a duration of > 5 years.

• Chronic or ongoing active infectious disease requiring systemic treatment.

• Clinically significant cardiac disease, or history of significant cerebrovascular disease.

Significant concurrent, uncontrolled medical conditions, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease

• Known or suspected HIV positive, positive serology for hepatitis B (HB), positive test for Hepatitis C, or positive plasma or white cell JC virus (JCV) PCR (either compartment).

• A circulating IgG level- Known hypersensitivity to components of the investigational medicinal product.

• Patients known or suspected of not being able to comply with a study protocol.

• Women of child bearing potential not will to use adequate contraception during study