Back to resultsA Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
P38 Inhibitor (4)
P38 Inhibitor (4)
P38 Inhibitor (4)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients with ACR 20 response
Secondary Outcome Measures
Percentage of patients with ACR 50/70 response.
Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00303563
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
P38 Inhibitor (4)
Intervention Description
50mg po qd
Intervention Type
Drug
Intervention Name(s)
P38 Inhibitor (4)
Intervention Description
150mg po qd
Intervention Type
Drug
Intervention Name(s)
P38 Inhibitor (4)
Intervention Description
300mg po qd
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po qd
Primary Outcome Measure Information:
Title
Percentage of patients with ACR 20 response
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of patients with ACR 50/70 response.
Time Frame
Week 12
Title
Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Aniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
City
Belmont
State/Province
North Carolina
ZIP/Postal Code
28012
Country
United States
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 6E2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
City
Split
ZIP/Postal Code
21000
Country
Croatia
City
Ceské Budejovice
ZIP/Postal Code
370 01
Country
Czech Republic
City
Praha
ZIP/Postal Code
128 50
Country
Czech Republic
City
Terezin
ZIP/Postal Code
411 55
Country
Czech Republic
City
Zlin
ZIP/Postal Code
760 01
Country
Czech Republic
City
Brest
ZIP/Postal Code
29609
Country
France
City
Corbeil-essonnes
ZIP/Postal Code
91106
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Paris
ZIP/Postal Code
75679
Country
France
City
Rouen
ZIP/Postal Code
76031
Country
France
City
Brescia
ZIP/Postal Code
25123
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Roma
ZIP/Postal Code
00161
Country
Italy
City
Guadalajara
ZIP/Postal Code
44340
Country
Mexico
City
Guadalajara
ZIP/Postal Code
44620
Country
Mexico
City
Miexico City
ZIP/Postal Code
06700
Country
Mexico
City
Brasov
ZIP/Postal Code
500366
Country
Romania
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
City
Johannesburg
ZIP/Postal Code
1619
Country
South Africa
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Granada
ZIP/Postal Code
18014
Country
Spain
City
Jerez de La Frontera
ZIP/Postal Code
11407
Country
Spain
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
City
Palma de Mallorca
ZIP/Postal Code
07007
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Kaohsiung
ZIP/Postal Code
00833
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
City
Tapei
ZIP/Postal Code
114
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis
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