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

This study has been completed.
Sponsor:
Information provided by:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00369928
First received: August 29, 2006
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: PG-760564
Drug: Placebo dose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    percent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks


Enrollment: 254
Study Start Date: August 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369928

  Show 53 Study Locations
Sponsors and Collaborators
Procter and Gamble
Investigators
Study Director: Muhammad Rehman, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Muhammad Rehman, MD, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00369928     History of Changes
Other Study ID Numbers: 2006012
Study First Received: August 29, 2006
Results First Received: August 4, 2011
Last Updated: August 4, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014