Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fostamatinib and placebo injections — DRUG
  Fostamatinib 100mg twice daily and placebo injection once every two weeks
• Fostamatinib and placebo injections — DRUG
  Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
• Fostamatinib and placebo injections — DRUG
  Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
• Adalimumab and placebo of fostamatinib — DRUG
  Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.
• Placebo of fostamatinib, fostamatinib, and placebo injections — DRUG
  Placebo injection once every two weeks. Placebo to fostamatinib for six weeks, followed by fostamatinib 100mg twice daily (Group F) / fostamatinib 100mg twice daily then 150mg once daily (Group G).

Study Details

The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an inadequate response to DMARDs. The study will last for approximately six months

Key Dates

Start date

Jan 31, 2011

Status verified

Apr 2014

Primary completion

Oct 31, 2012

Completion

Aug 31, 2013

Study Design

Enrollment

644 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dosing Group A
  Oral treatment and subcutaneous injection
• Experimental: Dosing Group B
  Oral treatment and subcutaneous injection
• Experimental: Dosing Group C
  Oral treatment and subcutaneous injection
• Active Comparator: Dosing Group D
  Oral treatment and subcutaneous injection
• Placebo Comparator: Dosing Group E
  Oral treatment and subcutaneous injection

Primary Outcome Measure

DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo [ Time Frame: Baseline and 6 weeks ]

Locations (40)

Find similar trials in Birmingham, AL

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