A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00316771
Collaborator
(none)
374
114
6
28
3.3
0.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
374 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date
:
Nov 1, 2005
Actual Primary Completion Date
:
Mar 1, 2008
Actual Study Completion Date
:
Mar 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: P38 Inhibitor (4) 150mg
|
Drug: P38 Inhibitor (4) 150mg
150mg po qd
|
| Experimental: P38 Inhibitor (4) 25mg
|
Drug: P38 Inhibitor (4) 25mg
25mg po bid
|
| Experimental: P38 Inhibitor (4) 300mg
|
Drug: P38 Inhibitor (4) 300mg
300mg po qd
|
| Experimental: P38 Inhibitor (4) 50mg
|
Drug: P38 Inhibitor (4) 50mg
50mg po qd
|
| Experimental: P38 Inhibitor (4) 75mg
|
Drug: P38 Inhibitor (4) 75mg
75mg po bid
|
| Placebo Comparator: Placebo
|
Drug: Placebo
po bid
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients with ACR 20 response [Week 12]
Secondary Outcome Measures
- Percentage of patients with ACR 50/70 response [Week 12]
- Change in ACR core set, DAS 28, HAQ disability index, SF-36, withdrawals, AEs, lab parameters. [Throughout study]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | 35242 | |
| 2 | Paradise Valley | Arizona | United States | 85253 | |
| 3 | Tucson | Arizona | United States | 85704 | |
| 4 | Tucson | Arizona | United States | 85711 | |
| 5 | Tucson | Arizona | United States | 85712 | |
| 6 | Escondido | California | United States | 92025 | |
| 7 | Fair Oaks | California | United States | 95628 | |
| 8 | Loma Linda | California | United States | 92357 | |
| 9 | Riverside | California | United States | 92501 | |
| 10 | Upland | California | United States | 91786 | |
| 11 | Gainesville | Florida | United States | 32607 | |
| 12 | Ocala | Florida | United States | 34474 | |
| 13 | Ormond Beach | Florida | United States | 32174 | |
| 14 | Sarasota | Florida | United States | 34232 | |
| 15 | Tamarac | Florida | United States | 33321 | |
| 16 | Atlanta | Georgia | United States | 30303 | |
| 17 | Atlanta | Georgia | United States | 30342 | |
| 18 | Macon | Georgia | United States | 31210 | |
| 19 | Nampa | Idaho | United States | 83687 | |
| 20 | Munster | Indiana | United States | 46321 | |
| 21 | South Bend | Indiana | United States | 46601 | |
| 22 | Wichita | Kansas | United States | 67207 | |
| 23 | Worcester | Massachusetts | United States | 01610 | |
| 24 | Traverse City | Michigan | United States | 49684 | |
| 25 | Omaha | Nebraska | United States | 68114 | |
| 26 | Toms River | New Jersey | United States | 08755 | |
| 27 | Albuquerque | New Mexico | United States | 87102 | |
| 28 | New Hartford | New York | United States | 13413 | |
| 29 | Rochester | New York | United States | 14618 | |
| 30 | Belmont | North Carolina | United States | 28012 | |
| 31 | North Fargo | North Dakota | United States | 58122 | |
| 32 | Tulsa | Oklahoma | United States | 74136 | |
| 33 | Bend | Oregon | United States | 97701 | |
| 34 | Camp Hill | Pennsylvania | United States | 17011 | |
| 35 | Pittsburgh | Pennsylvania | United States | 15237 | |
| 36 | Wilkes-barre | Pennsylvania | United States | 18711 | |
| 37 | Sioux Falls | South Dakota | United States | 57105 | |
| 38 | Jackson | Tennessee | United States | 38305 | |
| 39 | Knoxville | Tennessee | United States | 37909 | |
| 40 | Memphis | Tennessee | United States | 38104 | |
| 41 | Amarillo | Texas | United States | 79106 | |
| 42 | Bryan | Texas | United States | 77802 | |
| 43 | Carrollton | Texas | United States | 75007 | |
| 44 | Lubbock | Texas | United States | 79424 | |
| 45 | Norfolk | Virginia | United States | 23502 | |
| 46 | Everett | Washington | United States | 98201 | |
| 47 | Seattle | Washington | United States | 98133 | |
| 48 | Monroe | Wisconsin | United States | 53566 | |
| 49 | Caboolture | Australia | 4510 | ||
| 50 | Fitzroy | Australia | 3065 | ||
| 51 | Kippa Ring | Australia | 4021 | ||
| 52 | Curitiba | Brazil | 80060-240 | ||
| 53 | Goiania | Brazil | 74043-110 | ||
| 54 | Sao Paulo | Brazil | 04266-010 | ||
| 55 | Edmonton | Alberta | Canada | T5H 3V9 | |
| 56 | Winnipeg | Manitoba | Canada | R3N 0K6 | |
| 57 | St John's | Newfoundland and Labrador | Canada | A1A 5E8 | |
| 58 | Mississauga | Ontario | Canada | L5M 2V8 | |
| 59 | Ottawa | Ontario | Canada | K2G 6E2 | |
| 60 | Toronto | Ontario | Canada | M4K 1N2 | |
| 61 | Toronto | Ontario | Canada | M5T 2S8 | |
| 62 | Pointe-claire | Quebec | Canada | H9R 3J1 | |
| 63 | Tallinn | Estonia | 10128 | ||
| 64 | Tallinn | Estonia | 11312 | ||
| 65 | Tallinn | Estonia | 13419 | ||
| 66 | Bad Nauheim | Germany | 61231 | ||
| 67 | Berlin | Germany | 12200 | ||
| 68 | Berlin | Germany | 14059 | ||
| 69 | Erfurt | Germany | 99096 | ||
| 70 | Erlangen | Germany | 91054 | ||
| 71 | Leipzig | Germany | 04107 | ||
| 72 | Muenchen | Germany | 80336 | ||
| 73 | Wiesbaden | Germany | 65191 | ||
| 74 | Athens | Greece | 115 27 | ||
| 75 | Athens | Greece | 11521 | ||
| 76 | Heraklion | Greece | 71003 | ||
| 77 | Ioannina | Greece | 455 00 | ||
| 78 | Thessaloniki | Greece | 56403 | ||
| 79 | Dublin | Ireland | 4 | ||
| 80 | Dublin | Ireland | 9 | ||
| 81 | Guadalajara | Mexico | 44620 | ||
| 82 | Mexico City | Mexico | 03100 | ||
| 83 | Monterrey | Mexico | 64460 | ||
| 84 | San Luis Potosi | Mexico | 78240 | ||
| 85 | Auckland | New Zealand | 2025 | ||
| 86 | Christchurch | New Zealand | 8011 | ||
| 87 | Lower Hutt | New Zealand | 5010 | ||
| 88 | Elblag | Poland | 82-300 | ||
| 89 | Sopot | Poland | 81-759 | ||
| 90 | Szczecin | Poland | 71-252 | ||
| 91 | Torun | Poland | 87-100 | ||
| 92 | Warszawa | Poland | 02-256 | ||
| 93 | Warszawa | Poland | 02-637 | ||
| 94 | Bloemfontein | South Africa | 9301 | ||
| 95 | Cape Town | South Africa | 7500 | ||
| 96 | Durban | South Africa | 4001 | ||
| 97 | Johannesburg | South Africa | 1619 | ||
| 98 | Pretoria | South Africa | 0002 | ||
| 99 | Barcelona | Spain | 08003 | ||
| 100 | Barcelona | Spain | 08035 | ||
| 101 | Córdoba | Spain | 14004 | ||
| 102 | La Coruna | Spain | 15006 | ||
| 103 | La Laguna | Spain | 38320 | ||
| 104 | Lugo | Spain | 27004 | ||
| 105 | Madrid | Spain | 28034 | ||
| 106 | Sabadell | Spain | 08208 | ||
| 107 | Basingstoke | United Kingdom | RG24 9NA | ||
| 108 | Cannock | United Kingdom | WS11 5XY | ||
| 109 | Harrogate | United Kingdom | HG2 7SX | ||
| 110 | Leeds | United Kingdom | LS7 4SA | ||
| 111 | Newcastle Upon Tyne | United Kingdom | NE1 4LP | ||
| 112 | Southampton | United Kingdom | SO16 6YD | ||
| 113 | Wigan | United Kingdom | WN6 9EW | ||
| 114 | Wirral | United Kingdom | CH49 5PE |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00316771
Other Study ID Numbers:
- PA18439
First Posted:
Apr 21, 2006
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016