Back to resultsA Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
P38 Inhibitor (4) 150mg
P38 Inhibitor (4) 25mg
P38 Inhibitor (4) 300mg
P38 Inhibitor (4) 50mg
P38 Inhibitor (4) 75mg
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; 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
P38 Inhibitor (4) 150mg
P38 Inhibitor (4) 25mg
P38 Inhibitor (4) 300mg
P38 Inhibitor (4) 50mg
P38 Inhibitor (4) 75mg
Placebo
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, HAQ disability index, SF-36, withdrawals, AEs, lab parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00316771
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (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 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.
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
374 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P38 Inhibitor (4) 150mg
Arm Type
Experimental
Arm Title
P38 Inhibitor (4) 25mg
Arm Type
Experimental
Arm Title
P38 Inhibitor (4) 300mg
Arm Type
Experimental
Arm Title
P38 Inhibitor (4) 50mg
Arm Type
Experimental
Arm Title
P38 Inhibitor (4) 75mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
P38 Inhibitor (4) 150mg
Intervention Description
150mg po qd
Intervention Type
Drug
Intervention Name(s)
P38 Inhibitor (4) 25mg
Intervention Description
25mg po bid
Intervention Type
Drug
Intervention Name(s)
P38 Inhibitor (4) 300mg
Intervention Description
300mg po qd
Intervention Type
Drug
Intervention Name(s)
P38 Inhibitor (4) 50mg
Intervention Description
50mg po qd
Intervention Type
Drug
Intervention Name(s)
P38 Inhibitor (4) 75mg
Intervention Description
75mg po bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po bid
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, HAQ disability index, SF-36, withdrawals, AEs, lab 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;
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.
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
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
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
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
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
City
New Hartford
State/Province
New York
ZIP/Postal Code
13413
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Belmont
State/Province
North Carolina
ZIP/Postal Code
28012
Country
United States
City
North Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
City
Wilkes-barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
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
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
City
Monroe
State/Province
Wisconsin
ZIP/Postal Code
53566
Country
United States
City
Caboolture
ZIP/Postal Code
4510
Country
Australia
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
City
Kippa Ring
ZIP/Postal Code
4021
Country
Australia
City
Curitiba
ZIP/Postal Code
80060-240
Country
Brazil
City
Goiania
ZIP/Postal Code
74043-110
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3N 0K6
Country
Canada
City
St John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5E8
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 6E2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4K 1N2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
City
Pointe-claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
City
Tallinn
ZIP/Postal Code
10128
Country
Estonia
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Berlin
ZIP/Postal Code
14059
Country
Germany
City
Erfurt
ZIP/Postal Code
99096
Country
Germany
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
City
Athens
ZIP/Postal Code
115 27
Country
Greece
City
Athens
ZIP/Postal Code
11521
Country
Greece
City
Heraklion
ZIP/Postal Code
71003
Country
Greece
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
City
Dublin
ZIP/Postal Code
4
Country
Ireland
City
Dublin
ZIP/Postal Code
9
Country
Ireland
City
Guadalajara
ZIP/Postal Code
44620
Country
Mexico
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
City
Lower Hutt
ZIP/Postal Code
5010
Country
New Zealand
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
City
Sopot
ZIP/Postal Code
81-759
Country
Poland
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
City
Torun
ZIP/Postal Code
87-100
Country
Poland
City
Warszawa
ZIP/Postal Code
02-256
Country
Poland
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
City
Durban
ZIP/Postal Code
4001
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
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
City
Lugo
ZIP/Postal Code
27004
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
City
Basingstoke
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
City
Cannock
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
City
Harrogate
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
City
Wigan
ZIP/Postal Code
WN6 9EW
Country
United Kingdom
City
Wirral
ZIP/Postal Code
CH49 5PE
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
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