A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy

November 1, 2016 updated by: Hoffmann-La Roche

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

374

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Caboolture, Australia, 4510
      • Fitzroy, Australia, 3065
      • Kippa Ring, Australia, 4021
  • Brazil
      • Curitiba, Brazil, 80060-240
      • Goiania, Brazil, 74043-110
      • Sao Paulo, Brazil, 04266-010
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3N 0K6
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1A 5E8
    • Ontario
      • Mississauga, Ontario, Canada, L5M 2V8
      • Ottawa, Ontario, Canada, K2G 6E2
      • Toronto, Ontario, Canada, M4K 1N2
      • Toronto, Ontario, Canada, M5T 2S8
    • Quebec
      • Pointe-claire, Quebec, Canada, H9R 3J1
  • Estonia
      • Tallinn, Estonia, 10128
      • Tallinn, Estonia, 11312
      • Tallinn, Estonia, 13419
  • Germany
      • Bad Nauheim, Germany, 61231
      • Berlin, Germany, 12200
      • Berlin, Germany, 14059
      • Erfurt, Germany, 99096
      • Erlangen, Germany, 91054
      • Leipzig, Germany, 04107
      • Muenchen, Germany, 80336
      • Wiesbaden, Germany, 65191
  • Greece
      • Athens, Greece, 115 27
      • Athens, Greece, 11521
      • Heraklion, Greece, 71003
      • Ioannina, Greece, 455 00
      • Thessaloniki, Greece, 56403
  • Ireland
      • Dublin, Ireland, 4
      • Dublin, Ireland, 9
  • Mexico
      • Guadalajara, Mexico, 44620
      • Mexico City, Mexico, 03100
      • Monterrey, Mexico, 64460
      • San Luis Potosi, Mexico, 78240
  • New Zealand
      • Auckland, New Zealand, 2025
      • Christchurch, New Zealand, 8011
      • Lower Hutt, New Zealand, 5010
  • Poland
      • Elblag, Poland, 82-300
      • Sopot, Poland, 81-759
      • Szczecin, Poland, 71-252
      • Torun, Poland, 87-100
      • Warszawa, Poland, 02-637
      • Warszawa, Poland, 02-256
  • South Africa
      • Bloemfontein, South Africa, 9301
      • Cape Town, South Africa, 7500
      • Durban, South Africa, 4001
      • Johannesburg, South Africa, 1619
      • Pretoria, South Africa, 0002
  • Spain
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08035
      • Córdoba, Spain, 14004
      • La Coruna, Spain, 15006
      • La Laguna, Spain, 38320
      • Lugo, Spain, 27004
      • Madrid, Spain, 28034
      • Sabadell, Spain, 08208
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
      • Cannock, United Kingdom, WS11 5XY
      • Harrogate, United Kingdom, HG2 7SX
      • Leeds, United Kingdom, LS7 4SA
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
      • Southampton, United Kingdom, SO16 6YD
      • Wigan, United Kingdom, WN6 9EW
      • Wirral, United Kingdom, CH49 5PE
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
    • Arizona
      • Paradise Valley, Arizona, United States, 85253
      • Tucson, Arizona, United States, 85704
      • Tucson, Arizona, United States, 85711
      • Tucson, Arizona, United States, 85712
    • California
      • Escondido, California, United States, 92025
      • Fair Oaks, California, United States, 95628
      • Loma Linda, California, United States, 92357
      • Riverside, California, United States, 92501
      • Upland, California, United States, 91786
    • Florida
      • Gainesville, Florida, United States, 32607
      • Ocala, Florida, United States, 34474
      • Ormond Beach, Florida, United States, 32174
      • Sarasota, Florida, United States, 34232
      • Tamarac, Florida, United States, 33321
    • Georgia
      • Atlanta, Georgia, United States, 30303
      • Atlanta, Georgia, United States, 30342
      • Macon, Georgia, United States, 31210
    • Idaho
      • Nampa, Idaho, United States, 83687
    • Indiana
      • Munster, Indiana, United States, 46321
      • South Bend, Indiana, United States, 46601
    • Kansas
      • Wichita, Kansas, United States, 67207
    • Massachusetts
      • Worcester, Massachusetts, United States, 01610
    • Michigan
      • Traverse City, Michigan, United States, 49684
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • New Jersey
      • Toms River, New Jersey, United States, 08755
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
    • New York
      • New Hartford, New York, United States, 13413
      • Rochester, New York, United States, 14618
    • North Carolina
      • Belmont, North Carolina, United States, 28012
    • North Dakota
      • North Fargo, North Dakota, United States, 58122
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
    • Oregon
      • Bend, Oregon, United States, 97701
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
      • Pittsburgh, Pennsylvania, United States, 15237
      • Wilkes-barre, Pennsylvania, United States, 18711
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
    • Tennessee
      • Jackson, Tennessee, United States, 38305
      • Knoxville, Tennessee, United States, 37909
      • Memphis, Tennessee, United States, 38104
    • Texas
      • Amarillo, Texas, United States, 79106
      • Bryan, Texas, United States, 77802
      • Carrollton, Texas, United States, 75007
      • Lubbock, Texas, United States, 79424
    • Virginia
      • Norfolk, Virginia, United States, 23502
    • Washington
      • Everett, Washington, United States, 98201
      • Seattle, Washington, United States, 98133
    • Wisconsin
      • Monroe, Wisconsin, United States, 53566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
po bid
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with ACR 20 response
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with ACR 50/70 response
Time Frame: Week 12
Week 12
Change in ACR core set, DAS 28, HAQ disability index, SF-36, withdrawals, AEs, lab parameters.
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

April 20, 2006

First Submitted That Met QC Criteria

April 20, 2006

First Posted (Estimate)

April 21, 2006

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA18439

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on P38 Inhibitor (4) 150mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe