Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369928
Status:
COMPLETED
Last Update Posted:
2011-09-08
First Post:
2006-08-29
Brief Title:
Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis RA Patients Receiving Methotrexate
Sponsor:
Procter and Gamble
Organization:
Procter and Gamble
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None