A Phase 2 interventional study of SSR150106 and Placebos in Rheumatoid Arthritis, sponsored by Sanofi. Completed at 7 sites in 7 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-08.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
The primary objective of this study is to assess the reduction of systemic inflammation as measured by serum levels of C-reactive protein (CRP).
The secondary objectives are:
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 79 is below the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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90 micro grams oral solution once daily (QD)
Drug: SSR150106
90 micro grams oral solution once every other day (OEQD)
Drug: SSR150106
oral solution QD or OEQD
Drug: Placebos
Change from baseline in mean C-Reactive Protein level
Time frame: end of the 4-week double-blind treatment period
C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels
Time frame: at all time points measured
Improvement responder rates based on the American College of Rheumatology criteria
Time frame: at all time points measured
Pain relief (change from baseline)
Time frame: until day 14
Safety and tolerability
Time frame: During the entire study patient's participation
Plasma levels of SSR150106 and its first metabolite
Time frame: On a weekly basis during treatment phase, except at the end of the 3rd week
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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