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Completed

NCT Number: NCT00303563

A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis

This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or 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

Edmonton, Alberta, Canada

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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, with active RA;
  • receiving treatment for RA on an outpatient basis;
  • females of child-bearing potential, or nonsterilized males with partners of child-bearing potential, must use reliable contraception during, and for 4 weeks after, the study.

Exclusion criteria

  • major surgery within 8 weeks prior to screening;
  • rheumatic autoimmune disease or inflammatory joint disease other than RA;
  • treatment with methotrexate within 8 weeks of baseline;
  • concurrent use of DMARDs, including anti-TNF or other biologic therapy for RA.

Treatment and study plan

P38 Inhibitor (4)

Drug

50mg po qd

Placebo

Drug

po qd

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, FACIT-F fatigue assessment, AEs, laboratory parameters.

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-blind Study to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 17, 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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