Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425321
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2007-01-19
Brief Title:
Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Phase IIa Multicenter Randomized Double-Blind Placebo -Controlled Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Status:
COMPLETED
Status Verified Date:
2014-05
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:
The primary objective of the study is to evaluate the safety and tolerability of 100 200 and 300 mgday doses of RWJ-445380 for up to 12 weeks in patients with active Rheumatoid Arthritis despite methotrexate therapy
Detailed Description:
Trials with a new first -in-class drug will be done to ascertain safety tolerability and to explore efficacy in the treatment of rheumatoid arthritis including its effects on biomarkers Approximately 240 adult patients with rheumatoid arthritis despite the use of methotrexate therapy will be recruited for the study They will be randomly assigned to one of 4 treatment arms each patient has an equal chance of receiving the placebo or 100 mg 200 mg 300 mg dose of RWJ-445380 Patients will take the medication daily for up to 12 weeks Patients will receive study medication in a blinded fashion ie the patient the doctor and the study sponsor will not know what group the patient is in until all patients complete the study The investigator and the sponsor will monitor the study for the occurrence of possible side effects In addition to a screening visit patients will have visits every week for the first 2 weeks then every 2 weeks until 12 weeks of treatment After 12 weeks there will be a followup visit 4 weeks after the last dose of study drug is taken Medical history physical examination blood pressure heart rate temperature and ECGs are checked periodically Joints will be assessed to explore whether the drug might affect tender and swollen joints Blood samples will be taken for standard safety laboratory tests as well as special tests of the drug blood level biomarkers to see whether the drug might be affecting the biological pathway of antigen presentation and other markers for rheumatoid arthritis Samples will also be taken to see whether certain types of immune cells are affected by taking the drug Immunization with tetanus vaccine will be done to see if taking the drug might affect immune responses to this agent Patients will receive RWJ-445380 100 200 300 mg or placebo Patients will receive oral capsules daily for up to 12 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C-2006-009 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |