A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blind Study to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
    • Ontario
      • Ottawa, Ontario, Canada, K2G 6E2
      • Toronto, Ontario, Canada, M5T 2S8
  • Croatia
      • Rijeka, Croatia, 51000
      • Split, Croatia, 21000
  • Czech Republic
      • Ceské Budejovice, Czech Republic, 370 01
      • Praha, Czech Republic, 128 50
      • Terezin, Czech Republic, 411 55
      • Zlin, Czech Republic, 760 01
  • France
      • Brest, France, 29609
      • Corbeil-essonnes, France, 91106
      • Montpellier, France, 34295
      • Paris, France, 75679
      • Rouen, France, 76031
  • Italy
      • Brescia, Italy, 25123
      • Genova, Italy, 16132
      • Pavia, Italy, 27100
      • Roma, Italy, 00161
  • Mexico
      • Guadalajara, Mexico, 44620
      • Guadalajara, Mexico, 44340
      • Miexico City, Mexico, 06700
  • Romania
      • Brasov, Romania, 500366
      • Bucharest, Romania, 020125
  • Serbia
      • Belgrade, Serbia, 11000
  • South Africa
      • Bloemfontein, South Africa, 9301
      • Johannesburg, South Africa, 1619
      • Pretoria, South Africa, 0002
  • Spain
      • Barcelona, Spain, 08035
      • Granada, Spain, 18014
      • Jerez de La Frontera, Spain, 11407
      • La Coruna, Spain, 15006
      • Madrid, Spain, 28040
      • Oviedo, Spain, 33006
      • Palma de Mallorca, Spain, 07007
      • Sevilla, Spain, 41013
  • Taiwan
      • Kaohsiung, Taiwan, 00833
      • Taoyuan, Taiwan, 333
      • Tapei, Taiwan, 114
  • United States
    • Alabama
      • Aniston, Alabama, United States, 36207
    • Arizona
      • Scottsdale, Arizona, United States, 85251
      • Tucson, Arizona, United States, 85704
      • Tucson, Arizona, United States, 85712
    • California
      • Escondido, California, United States, 92025
      • Loma Linda, California, United States, 92357
    • Connecticut
      • Stamford, Connecticut, United States, 06905
    • Illinois
      • Morton Grove, Illinois, United States, 60053
    • Indiana
      • South Bend, Indiana, United States, 46601
    • Kansas
      • Wichita, Kansas, United States, 67207
    • Kentucky
      • Louisville, Kentucky, United States, 40292
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
    • North Carolina
      • Belmont, North Carolina, United States, 28012
    • Oregon
      • Bend, Oregon, United States, 97701
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
      • Lancaster, Pennsylvania, United States, 17604
    • South Carolina
      • Charleston, South Carolina, United States, 29407
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
      • Memphis, Tennessee, United States, 38104
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Amarillo, Texas, United States, 79106
      • Dallas, Texas, United States, 75231

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, 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.

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
Experimental: 1
Drug: P38 Inhibitor (4)
50mg po qd
Drug: P38 Inhibitor (4)
150mg po qd
Drug: P38 Inhibitor (4)
300mg po qd
Experimental: 2
Drug: P38 Inhibitor (4)
50mg po qd
Drug: P38 Inhibitor (4)
150mg po qd
Drug: P38 Inhibitor (4)
300mg po qd
Experimental: 3
Drug: P38 Inhibitor (4)
50mg po qd
Drug: P38 Inhibitor (4)
150mg po qd
Drug: P38 Inhibitor (4)
300mg po qd
Placebo Comparator: 4
Drug: Placebo
po qd

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, FACIT-F fatigue assessment, AEs, laboratory 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

April 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 16, 2006

First Submitted That Met QC Criteria

March 16, 2006

First Posted (Estimate)

March 17, 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

  • PA18604

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.

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