Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fostamatinib disodium (R935788) — DRUG
  100 mg tablet, orally, twice-a-day
• Fostamatinib disodium (R935788) — DRUG
  150 mg tablet, orally, once a day
• Placebo — DRUG
  Placebo, orally, either once a day, or twice a day

Study Details

The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate.

Key Dates

Start date

May 31, 2008

Status verified

Aug 2016

Primary completion

Jun 30, 2009

Completion

Jun 30, 2009

Study Design

Enrollment

457 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1
  R788, 100 mg tablet, orally, twice-a-day
• Experimental: 2
  R788, 150 mg tablet, orally, once a day
• Placebo Comparator: 3
  Placebo, orally, either once a day, or twice a day

Primary Outcome Measure

American College of Rheumatology 20 (ACR20) Response at 6 Months [ Time Frame: 6 months ]

Locations (24)

Find similar trials in La Jolla, CA

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