Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
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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 |
- 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 |
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
Show 53 Study Locations| 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 Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013