Clinical trial NCT00303563: A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-03-17
Enrollment: 204
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 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.


Eligibility criteria: 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.

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, FACIT-F fatigue assessment, AEs, laboratory parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Aniston
country: United States
state: Alabama
city: Scottsdale
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: Loma Linda
country: United States
state: California
city: Stamford
country: United States
state: Connecticut
city: Morton Grove
country: United States
state: Illinois
city: South Bend
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Belmont
country: United States
state: North Carolina
city: Bend
country: United States
state: Oregon
city: Danville
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Edmonton
country: Canada
state: Alberta
city: Halifax
country: Canada
state: Nova Scotia
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Rijeka
country: Croatia
city: Split
country: Croatia
city: Ceské Budejovice
country: Czech Republic
city: Praha
country: Czech Republic
city: Terezin
country: Czech Republic
city: Zlin
country: Czech Republic
city: Brest
country: France
city: Corbeil-essonnes
country: France
city: Montpellier
country: France
city: Paris
country: France
city: Rouen
country: France
city: Brescia
country: Italy
city: Genova
country: Italy
city: Pavia
country: Italy
city: Roma
country: Italy
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Miexico City
country: Mexico
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Belgrade
country: Serbia
city: Bloemfontein
country: South Africa
city: Johannesburg
country: South Africa
city: Pretoria
country: South Africa
city: Barcelona
country: Spain
city: Granada
country: Spain
city: Jerez de La Frontera
country: Spain
city: La Coruna
country: Spain
city: Madrid
country: Spain
city: Oviedo
country: Spain
city: Palma de Mallorca
country: Spain
city: Sevilla
country: Spain
city: Kaohsiung
country: Taiwan
city: Taoyuan
country: Taiwan
city: Tapei
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: