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Sponsored by: |
Genmab |
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Information provided by: | Genmab |
ClinicalTrials.gov Identifier: | NCT00291928 |
The purpose of this study is to evaluate the safety and effectiveness of HuMax-CD20 in patients with active Rheumatoid Arthritis.
Condition | Intervention | Phase |
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Acute Rheumatic Arthritis |
Drug: HuMax-CD20 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo Controlled, Dose Escalation, Multi-Center Phase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Active Rheumatoid Arthritis Who Have Previously Failed One or More DMARDs |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Active disease at the time of screening as defined by :
Treatment failure to one or more DMARDs.
Applicable only to patients on methotrexate therapy at time of screening:
Treatment with methotrexate for at least 12 weeks prior to planned start of trial treatment (Visit 2), with possible interruption of treatment of maximum two weeks in total, in the period 5-12 weeks from Visit 2.
Applicable only to patients on methotrexate therapy at time of screening:
Treatment with a stable dose of methotrexate (7.5 – 25 mg/week, p.o., i.m., and/or s.c.) for at least four weeks prior to planned start of trial treatment (Visit 2)
Exclusion criteria:
Within four weeks prior to planned start of trial treatment (Visit 2):
Past or current malignancy, except for
Screening laboratory values:
Study Director: | Dorthe Grønnegaard, Msc. Pharm | Genmab |
Study ID Numbers: | Hx-CD20-403 |
Study First Received: | February 14, 2006 |
Last Updated: | November 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00291928 |
Health Authority: | United States: Food and Drug Administration |
Bacterial Infections Autoimmune Diseases Joint Diseases Arthritis, Rheumatoid Acute articular rheumatism Rheumatic Fever Rheumatic Diseases Fever |
Antibodies Gram-Positive Bacterial Infections Musculoskeletal Diseases Streptococcal Infections Arthritis Connective Tissue Diseases Immunoglobulins |
Immune System Diseases |