Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or Sulfasalazine

Phase 2

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00062465
• Lead Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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.

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 and/or 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 Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-06-05
• Study First Submitted QC: 2003-06-05
• Study First Posted: 2003-06-06
• Status Verified: 2006-03
• Study Completion: 2006-03
• Last Update Submitted: 2008-03-03
• Last Update Posted: 2008-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); 🇺🇸 Bethesda, Maryland, United States