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Trial information
A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
Status: Completed
Protocol number: PA18439
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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.
Brief 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.
Target sample size is 440.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; 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, HAQ disability index, SF-36, withdrawals, AEs, lab parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 12/13/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:Australia Brazil - Curitiba
- Goiania
- Sao Paulo
Canada - Winnipeg, MB
- St John'S
- Ottawa, ON
- Pointe-Claire, QC
- Sainte-Foy, QC
Estonia Germany - Berlin
- Erfurt
- Leipzig
- Wiesbaden
Greece - Athens
- Heraklion
- Ioannina
Mexico - Guadalajara
- Monterrey
- San Luis Potosi
New Zealand Poland - Elblag
- Sopot
- Szczecin
- Torun
- Warszawa
South Africa - Bloemfontein
- Cape Town
- Durban
- Johannesburg
- Pretoria
Spain - La Coruna
- La Laguna
- Sabadell
United Kingdom - Basingstoke
- Leeds
- Newcastle upon Tyne
- Wirral
United States - Birmingham, AL
- Paradise Valley, AZ
- Tucson , AZ
- Escondido, CA
- Fair Oaks, CA
- Loma Linda, CA
- Riverside, CA
- Upland, CA
- Gainesville, FL
- Ormond Beach, FL
- Sarasota , FL
- Atlanta, GA
- Macon , GA
- Nampa, ID
- Munster, IN
- South Bend, IN
- Wichita, KS
- Omaha, NE
- Toms River, NJ
- Albuquerque, NM
- North Fargo, ND
- Bend, OR
- Camp Hill, PA
- Wexford, PA
- Jackson, TN
- Knoxville, TN
- Memphis , TN
- Amarillo, TX
- Carrollton, TX
- Lubbock, TX
- Seattle, WA
- Monroe, WI
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