Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate

August 4, 2011 updated by: Procter and Gamble

A Multicenter, Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG-760564 in Adult Patients With RA Receiving Methotrexate

This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. After the washout period, patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in North America and Europe at approximately 50 to 60 sites. Approximately 270 patients will be randomized, of which 189 are expected to complete the study.

The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. The washout period will be 4 weeks for sulfasalazine, hydroxychloroquine, azathioprine, D-penicillamine, etanercept, and anakinra, 8 weeks for gold, infliximab, and adalimumab, and 12 weeks for abatacept.

After the washout period, the patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits (Weeks 1, 2, 4, 6, 8, and 12) and a follow-up visit 4 weeks after the last treatment visit (Week 16). Patients will not initiate new therapies until after the 4-week follow-up is completed. Liver function tests will be evaluated at every visit.

The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.

Study Type

Interventional

Enrollment (Actual)

254

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

  • Czech Republic
      • Ceska Lipa, Czech Republic
        • Research Facility
      • Hustopece, Czech Republic
        • Research Facility
      • Prague, Czech Republic
        • Research Facility
      • Uherske Hradiste, Czech Republic
        • Research Facility
      • Zlin, Czech Republic
        • Research Facility
  • Hungary
      • Balatonfüred, Hungary
        • Research Facility
      • Budapest, Hungary
        • Research Facility
      • Eger, Hungary
        • Research Facility
      • Gyor, Hungary
        • Research Facility
      • Gyula, Hungary
        • Research Facility
      • Szolnok, Hungary
        • Research Facility
  • Netherlands
      • Den Haag, Netherlands, 2545 CH
        • Research Facility
  • Poland
      • Częstochowa, Poland, 42-200
        • Research Facility
      • Działdowo, Poland, 13-200
        • Research Facility
      • Elbląg, Poland, 83-300
        • Research Facility
      • Konskie, Poland, 26-200
        • Research Facility
      • Krakow, Poland, 30-510
        • Research Facility
      • Krakow, Poland, 31-121
        • Research Facility
      • Lodz, Poland, 33-513
        • Research Facility
      • Lublin, Poland, 20-954
        • Research Facility
      • Poznań, Poland, 60-733
        • Research Facility
      • Sopot, Poland, 81-759
        • Research Facility
      • Szczecin, Poland, 71-252
        • Research Facility
      • Torun, Poland, 85-168
        • Research Facility
      • Warszawa, Poland, 00-909
        • Research Facility
  • United Kingdom
      • Ashford, United Kingdom, TW15 3AA
        • Research Facility
      • Cambridge, United Kingdom
        • Research Facility
      • Glasgow, United Kingdom, G20 0XA
        • Research Facility
      • Liverpool, United Kingdom, L9 7AL
        • Research Facility
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Research Facility
    • California
      • Beverly Hills, California, United States, 90211
        • Research Facility
      • Mission Viejo, California, United States, 92691
        • Research Facility
    • Florida
      • Chiefland, Florida, United States, 32626
        • Research Facility
      • Dunedin, Florida, United States, 34698
        • Research Facility
      • Ft. Lauderdale, Florida, United States, 33334
        • Research Facility
      • Tavares, Florida, United States, 32778
        • Research Facility
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Research Facility
      • Marietta, Georgia, United States, 30060
        • Research Facility
      • Rome, Georgia, United States, 30165
        • Research Facility
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Research Facility
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Research Facility
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Research Facility
    • New Jersey
      • Elizabeth, New Jersey, United States, 07202
        • Research Facility
    • New York
      • Plainview, New York, United States, 11803
        • Research Facility
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Research Facility
      • Wilmington, North Carolina, United States, 28401
        • Research Facility
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Research Facility
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Facility
      • Erie, Pennsylvania, United States, 16508
        • Research Facility
    • Texas
      • Austin, Texas, United States, 78705
        • Research Facility
      • Dallas, Texas, United States, 75231
        • Research Facility
      • Dallas, Texas, United States, 75235
        • Research Facility
      • San Antonio, Texas, United States, 78217
        • Research Facility

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 to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis
  • Disease duration of at least 6 months
  • Must be treated with Methotrexate for at least 24 weeks
  • At least 6 swollen joints and 6 tender joints
  • Washout required for other Disease Modifying Anti-rheumatic Drugs (DMARDs)
  • Women of childbearing age and all males must use acceptable method of birth control

Exclusion Criteria:

  • Tuberculosis
  • Malignancies
  • Abnormal electrocardiograms as described in the protocol
  • Current infection or recurrent infections or immunodeficiency
  • Liver diseases and abnormalities in liver function tests as described in the protocol
  • Autoimmune diseases other than RA except Sjogren's syndrome secondary to RA;
  • History of demyelization diseases
  • Any condition that in the opinion of the investigator could be detrimental to patients enrolling in the study including clinically important changes in laboratory values and other diseases described in the protocol

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo, oral dose, BID
Drug: Placebo dose
placebo, BID, oral for 12 weeks
Experimental: 25 mg PG-760564
25 mg BID, of oral PG-760564
Drug: PG-760564
100 mg BID, of oral PG-760564
Drug: PG-760564
25 mg BID, of oral PG-760564
Experimental: 100 mg PG-760564
100 mg BID, of oral PG-760564
Drug: PG-760564
100 mg BID, of oral PG-760564
Drug: PG-760564
25 mg BID, of oral PG-760564

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks
Time Frame: 12 weeks
percent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Procter and Gamble

Investigators

  • Study Director: Muhammad Rehman, MD, Procter and Gamble

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

August 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

August 29, 2006

First Submitted That Met QC Criteria

August 29, 2006

First Posted (Estimate)

August 30, 2006

Study Record Updates

Last Update Posted (Estimate)

September 8, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006012

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.

Subscribe