Status:
TERMINATED
Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403
Lead Sponsor:
GlaxoSmithKline
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 evalu...
Detailed Description
All patients who fulfill the eligibility criteria for this trial , will initiate at least one treatment course of ofatumumab, and depending of subsequent worsening in disease activity will be eligible...
Eligibility Criteria
Inclusion
- 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
- 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 \<lower limit of normal.
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2013
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00655824
Start Date
January 1 2008
End Date
March 19 2013
Last Update
December 5 2017
Active Locations (10)
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1
GSK Investigational Site
Los Angeles, California, United States, 90095
2
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33334
3
GSK Investigational Site
New York, New York, United States, 10003
4
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635