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

Stopped early · Phase 2

Conditions studied: Arthritis, Rheumatoid

In brief

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.

Key facts

Study ID

NCT00655824

Run by

GlaxoSmithKline

People needed

124

Starts

2008-01-01

Expected to finish

2013-03-19

Last updated by the study team

2017-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Duncansville, Pennsylvania, United States
• GSK Investigational Site — Copenhagen, Denmark
• GSK Investigational Site — Glostrup Municipality, Denmark
• GSK Investigational Site — Hellerup, Denmark
• GSK Investigational Site — Szombathely, Hungary
• GSK Investigational Site — Warsaw, Poland
• GSK Investigational Site — Ipswich, United Kingdom

Full record on ClinicalTrials.gov

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