Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062465
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-06-05
Brief Title:
Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or Sulfasalazine
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A 24-Week Double Blind Randomized Study to Determine the Effects of 24 Weeks of Dosing With Tripterygium Wilfordii Hook F TwHF or Sulfasalazine in Subjects With Active Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2006-03
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:
Various forms of the plant extract Tripterygium wilfordi Hook F TwHF have been used in China as a remedy for inflammatory diseases including rheumatoid arthritis The purpose of this study is to investigate how tolerable safe and effective TwHF is for patients with rheumatoid arthritis Investigators will compare the therapeutic effects of TwHF with Sulfasalazine an FDA-approved drug for arthritis
Participants in this 24-week study must have had active rheumatoid arthritis for at least six months Approximately 120 patients will participate Participants will be assigned to one of two drug-treatment groups TwHF or Sulfasalazine They will be given the study drug at each of six clinic visits and will be asked to take two capsules three times each day with meals and water During the clinic visits investigators will obtain multiple blood samples give physical exams assess swollen tender and painful joints and administer x-rays
Study participants will be compensated up to 260 for their involvement in this study
Participants in this 24-week study must have had active rheumatoid arthritis for at least six months Approximately 120 patients will participate Participants will be assigned to one of two drug-treatment groups TwHF or Sulfasalazine They will be given the study drug at each of six clinic visits and will be asked to take two capsules three times each day with meals and water During the clinic visits investigators will obtain multiple blood samples give physical exams assess swollen tender and painful joints and administer x-rays
Study participants will be compensated up to 260 for their involvement in this study
Detailed Description:
This is a multi-center randomized active treatment controlled phase II study in patients with either new onset or therapy resistant rheumatoid arthritis RA This study will be conducted at 7 sites with NIAMS being the coordinating center and 6 external centers Tripterygium wilfordii Hook F TwHF is a traditional medicinal plant that is and has been used in China for many years to treat inflammatory conditions including RA This study we will be testing if a standardized plant extract from the roots of TwHF is superior to Sulfasalazine in improving the signs and symptoms in subjects with RA as assessed by the ACR 20 criteria Those subjects who qualify for the study will be allowed to continue on stable doses of NSAID therapy andor low dose corticosteroids but will discontinue any DMARDs or biologicals prior to the start of the study Study subjects will then be randomized to receive either TwHF or Sulfasalazine and subjects will remain on double blind medication for 24 weeks Patients will be assessed at baseline 2 weeks and every 4 weeks thereafter using a standardized joint exam questionnaires and laboratory measures for inflammation ACR 20 responses will be calculated at each visit and compared in both groups at the end of evaluation at 24 weeks Safety will be monitored throughout the trial This is the first study that compares the extract of TwHF to a currently used DMARD in treating patients with RA and will help to define the role of new anti-inflammatory and possibly disease modifying agents in treating patients with RA
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 |
|---|---|---|---|
| 03-AR-0208 | None | None | None |