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

Rheumatoid Arthritis Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303563
• Other study ID #: PA18604
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2006
• Last updated: November 1, 2016
• Start date: April 2006
• Est. completion date: December 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• P38 Inhibitor (4)
50mg po qd
• P38 Inhibitor (4)
150mg po qd
• P38 Inhibitor (4)
300mg po qd
• Placebo
po qd

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  Croatia,  Czech Republic,  France,  Italy,  Mexico,  Romania,  Serbia,  South Africa,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with ACR 20 response		Week 12	No
Secondary	Percentage of patients with ACR 50/70 response.		Week 12	No
Secondary	Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters.		Throughout study	No