Trial information
A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis
Status: Completed
Protocol number: PA18604
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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.
Brief 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. Target sample size is
200.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: P38 Inhibitor (4)
Primary outcome: 1. Percentage of patients with ACR 20 response Time frame: Week 12
Key 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
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 03/10/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Canada
Croatia
Czech Republic
- Ceské Budejovice
- Praha
- Terezin
- Zlin
France
Italy
Mexico
Romania
Serbia and Montenegro
South Africa
- Bloemfontein
- Johannesburg
- Pretoria
Spain
- Barcelona
- La Coruna
- Oviedo
Taiwan
United States
- Aniston, AL
- Scottsdale, AZ
- Tucson , AZ
- Escondido, CA
- Stamford, CT
- Morton Grove, IL
- South Bend, IN
- Wichita, KS
- New Orleans, LA
- Belmont, NC
- Bend, OR
- Danville, PA
- Lancaster, PA
- Knoxville, TN
- Memphis , TN
- Amarillo, TX
- Dallas, TX
