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

NCT01264770 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 644

Last updated 2014-05-06

Study results available
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Summary

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

Conditions

Interventions

DRUG

Fostamatinib and placebo injections

Fostamatinib 100mg twice daily and placebo injection once every two weeks

DRUG

Fostamatinib and placebo injections

Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks

DRUG

Fostamatinib and placebo injections

Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.

DRUG

Adalimumab and placebo of fostamatinib

Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.

DRUG

Placebo of fostamatinib, fostamatinib, and placebo injections

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).

Sponsors & Collaborators

Principal Investigators

  • Neil MacKillop, MD PhD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-10-31
Completion
2013-08-31

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • Russia
  • Slovakia
  • South Africa
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01264770 on ClinicalTrials.gov