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NCT00062465 · ClinicalTrials.gov registry record · Phase 2

Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or Sulfasalazine

A Phase 2 study of Rheumatoid Arthritis, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Completed
Registry status
Phase 2
Development phase
157
Enrollment target
1
Study location

NCT00062465 is a Phase 2 study of Rheumatoid Arthritis that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 157 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00062465, a Phase 2 study of Rheumatoid Arthritis, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

COMPLETED
Registry status
Phase 2
Development phase
157 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Rheumatoid Arthritis

Interventions

  • DRUG TwHF

Study Locations (1)

Maryland

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) - Bethesda

Trial Details

FieldValue
Enrollment Target 157 participants
Start Date 2003-06
Est. Completion 2006-03
Phase Phase 2

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

93 total trials

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What the Registry Record Tells You About NCT00062465

The ClinicalTrials.gov registry entry for NCT00062465 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 157 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (97% lower). The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which TwHF is the first listed.

NCT00062465 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00062465 about?

NCT00062465 is a clinical study titled "Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or Sulfasalazine". 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. Investi...

What is the current status of trial NCT00062465?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 157 participants. The study started on 2003-06. Estimated completion is 2006-03.

What conditions does trial NCT00062465 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis.

What interventions are being tested in trial NCT00062465?

The interventions under investigation include: TwHF (DRUG).

Who is sponsoring clinical trial NCT00062465?

This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00062465 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.