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Completed

NCT Number: NCT00316771

A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy

This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75 bid po) or placebo, and will remain on the stable dose of methotrexate. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Caboolture, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients >=18 years of age;
  • active rheumatoid arthritis;
  • current inadequate clinical response to methotrexate.

Exclusion criteria

  • receiving any other disease-modifying anti-rheumatic drug, with the exception of hydroxychloroquine or chloroquine.

Treatment and study plan

P38 Inhibitor (4) 150mg

Drug

150mg po qd

P38 Inhibitor (4) 25mg

Drug

25mg po bid

P38 Inhibitor (4) 300mg

Drug

300mg po qd

P38 Inhibitor (4) 50mg

Drug

50mg po qd

P38 Inhibitor (4) 75mg

Drug

75mg po bid

Placebo

Drug

po bid

Primary outcomes

  1. Percentage of patients with ACR 20 response

    Time frame: Week 12

Secondary outcomes

  1. Percentage of patients with ACR 50/70 response

    Time frame: Week 12

  2. Change in ACR core set, DAS 28, HAQ disability index, SF-36, withdrawals, AEs, lab parameters.

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy.

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Apr 21, 2006
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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