Status:
COMPLETED
Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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/d...
Eligibility Criteria
Inclusion
- Key
- 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
- 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)
Key Trial Info
Start Date :
June 13 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00686868
Start Date
June 13 2008
End Date
May 2 2011
Last Update
June 26 2017
Active Locations (17)
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1
GSK Investigational Site
Anniston, Alabama, United States, 36207
2
GSK Investigational Site
Miramar, Florida, United States, 33025
3
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
4
GSK Investigational Site
Adelaide, South Australia, Australia, 5000