Clinical trial NCT00316771: A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-04-21
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients with ACR 20 response
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of patients with ACR 50/70 response
timeFrame: Week 12
measure: Change in ACR core set, DAS 28, HAQ disability index, SF-36, withdrawals, AEs, lab parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Paradise Valley
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Escondido
country: United States
state: California
city: Fair Oaks
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Riverside
country: United States
state: California
city: Upland
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Nampa
country: United States
state: Idaho
city: Munster
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Worcester
country: United States
state: Massachusetts
city: Traverse City
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Toms River
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: New Hartford
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Belmont
country: United States
state: North Carolina
city: North Fargo
country: United States
state: North Dakota
city: Tulsa
country: United States
state: Oklahoma
city: Bend
country: United States
state: Oregon
city: Camp Hill
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Wilkes-barre
country: United States
state: Pennsylvania
city: Sioux Falls
country: United States
state: South Dakota
city: Jackson
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Bryan
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Everett
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Monroe
country: United States
state: Wisconsin
city: Caboolture
country: Australia
city: Fitzroy
country: Australia
city: Kippa Ring
country: Australia
city: Curitiba
country: Brazil
city: Goiania
country: Brazil
city: Sao Paulo
country: Brazil
city: Edmonton
country: Canada
state: Alberta
city: Winnipeg
country: Canada
state: Manitoba
city: St John's
country: Canada
state: Newfoundland and Labrador
city: Mississauga
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Pointe-claire
country: Canada
state: Quebec
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Bad Nauheim
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Erfurt
country: Germany
city: Erlangen
country: Germany
city: Leipzig
country: Germany
city: Muenchen
country: Germany
city: Wiesbaden
country: Germany
city: Athens
country: Greece
city: Athens
country: Greece
city: Heraklion
country: Greece
city: Ioannina
country: Greece
city: Thessaloniki
country: Greece
city: Dublin
country: Ireland
city: Dublin
country: Ireland
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: San Luis Potosi
country: Mexico
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Lower Hutt
country: New Zealand
city: Elblag
country: Poland
city: Sopot
country: Poland
city: Szczecin
country: Poland
city: Torun
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Bloemfontein
country: South Africa
city: Cape Town
country: South Africa
city: Durban
country: South Africa
city: Johannesburg
country: South Africa
city: Pretoria
country: South Africa
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: La Coruna
country: Spain
city: La Laguna
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Sabadell
country: Spain
city: Basingstoke
country: United Kingdom
city: Cannock
country: United Kingdom
city: Harrogate
country: United Kingdom
city: Leeds
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Southampton
country: United Kingdom
city: Wigan
country: United Kingdom
city: Wirral
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: