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

Rheumatoid Arthritis Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316771
• Other study ID #: PA18439
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2006
• Last updated: November 1, 2016
• Start date: November 2005
• Est. completion date: March 2008

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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) 150mg
150mg po qd
• P38 Inhibitor (4) 25mg
25mg po bid
• P38 Inhibitor (4) 300mg
300mg po qd
• P38 Inhibitor (4) 50mg
50mg po qd
• P38 Inhibitor (4) 75mg
75mg po bid
• Placebo
po bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Estonia,  Germany,  Greece,  Ireland,  Mexico,  New Zealand,  Poland,  South Africa,  Spain,  United Kingdom, 

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, HAQ disability index, SF-36, withdrawals, AEs, lab parameters.		Throughout study	No