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Clinical Trials

Date: 2011-04-15

Type of information:

phase: 2

Announcement: discontinuation of the trial

Company: Galapagos (Belgium)

Product: GLPG0259

Action mechanism:

Disease: rheumatoid arthritis

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Country:

Trial details:

Latest news: Galapagos has announced that it will discontinue its Phase II clinical trial for GLPG0259 in rheumatoid arthritis. This decision is based on the outcome of a planned interim analysis which did not support the continuation of GLPG0259\'s development for rheumatoid arthritis. An Interim Review Committee of key opinion leaders in the field of rheumatology analyzed unblinded safety and efficacy data from the first 30 patients. Twenty patients received GLPG0259 and ten patients received placebo for a twelve week period. No serious adverse events or safety signals were reported. However, the committee recommended that study be discontinued due to limited efficacy potential of the compound in the Phase II trial. Galapagos intends to complete a full analysis of the data package prior to making a decision on the next steps for GLPG0259, including the position of the compound in other indications.

Is general: Yes