Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fostamatinib — DRUG
  Fostamatinib 100mg twice daily.
• Adalimumab — DRUG
  Adalimumab 40 mg by subcutaneous injection every 2 weeks for 24 weeks.
• Placebo of Fostamatinib — DRUG
  Placebo bid for 6 weeks.
• Placebo of Adalimumab — DRUG
  Placebo injection once every two weeks.

Study Details

This is a sub-study of the OSKIRA-4 study, (D4300C0004, NCT01264770) to explore alternative and more sensitive modalities for measuring the beneficial effects of syk inhibition with fostamatinib in patients with active RA. This MRI sub-study was reported later than the main study due to recruitment delays at specialist imaging sites and so is registered and presented entirely separately to the main study results. This study will investigate the impact of treatment on joint activity and damage by assessing synovitis, osteitis, bone erosions and joint space narrowing.

Key Dates

Start date

Feb 28, 2011

Status verified

Apr 2014

Primary completion

Jul 31, 2013

Completion

Jul 31, 2013

Study Design

Enrollment

198 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dosing Group A
  Oral treatment and subcutaneous injection.
• Active Comparator: Dosing Group D
  Oral treatment and subcutaneous injection.
• Placebo Comparator: Dosing Group E
  Placebo bid for 6 weeks followed by switch to 100 mg fostamatinib bid for 24 weeks, plus placebo subcutaneous injection every 2 weeks.

Primary Outcome Measure

OMERACT RAMRIS Synovitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren) [ Time Frame: Baseline, 6 and 24 weeks ]

Locations (6)

Find similar trials in Glendale, AZ

Related Studies

• Physica System Total Knee Replacement Registry Study
  Recruiting · Limacorporate S.p.a · Rancho Mirage, California
• Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
  PHASE1 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• RA-PRO PRAGMATIC TRIAL
  PHASE3 · Recruiting · University of Alabama at Birmingham · Auburn, Alabama
• Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas