Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients

• Status: Completed
• Trial end date: 2011-05-02
• Target enrollment: 0
• Participant gender: All

Summary

This study will examine the safety and tolerability, PK and PD of subcutaneously administered GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Key Inclusion Criteria:

• Male or female aged ≥ 18 years

• A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification) of at least six months prior to screening

• Subjects must be treated with MTX, 7.5-25 mg/week, for at least 12 weeks prior to Visit 2, with the last 4 weeks prior to Day 2 at a stable dosage

• Patient must be willing to receive folic acid ≥5mg/wk 4 weeks prior to baseline administered according to locally accepted practice

• Body mass index (BMI) < 35kg/m2 (inclusive)

• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Key Exclusion Criteria:

• Subjects with a history of a rheumatic autoimmune disease other than RA (except secondary Sjögren's syndrome), or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty's syndrome)

• Previous exposure to biologic cell depleting anti-rheumatic therapies, including investigational compounds (e.g. anti-CD11a, anti-CD19, anti-CD20, anti-CD22, anti-BLyS/BAFF, anti-CD3, anti-CD4, anti-CD5, anti-CD52)

• Exposure to etanercept < 4 weeks, infliximab or adalimumab < 8 weeks, or abatacept or anakinra < 12 weeks prior to visit 2

• Received any of the following treatments within 4 weeks prior to Visit 2:

• Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues, monoclonal antibodies)

• Glucocorticoid unless given in doses equivalent to ≤ 10 mg of prednisolone /day

• Intra-articular, i.m. or IV corticosteroids

• Live/attenuated vaccinations

• Cyclosporine

• Azathioprine

• Penicillamine

• Sulfasalazine

• Bucillamine

• Hydroxychloroquine

• Chloroquine

• Exposure to leflunomide within 12 weeks prior to visit 2 unless the subject has completed peroral cholestyramine treatment

• Exposure to gold therapy ≤ 12 weeks prior to Visit 2

• Exposure to IV immunogammaglobulins ≤ 24 weeks prior to Visit 2

• Past or current malignant melanoma

• Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, renal infection, chest infection with bronchiectasis, tuberculosis and active hepatitis B and C

• History of significant cerebrovascular disease

• Positive plasma / white cell JC Virus (JCV) PCR (either compartment)