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Rheumatoid ArthritisPhase 2NCT00062465

Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or Sulfasalazine

A Phase 2 study testing TwHF in people with Rheumatoid Arthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
TwHF
How many people
157 participants
Where
1 siteUnited States
Study dates
Jun 2003to Mar 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male and female outpatients between 18 and 75 years of age
  • Females must be of non-childbearing potential (post-menopausal, surgically sterilized or post hysterectomy) or using a double-barrier method of birth control for the duration of the study. A protocol acceptable method of double barrier method of birth control includes any combination of two or three of the following: condom, spermicidal and diaphragm.
  • Documented diagnosis of rheumatoid arthritis of at least six (6) months duration, as defined by the American Rheumatism Association 1987 Revised Criteria
  • American Rheumatism Association Functional Class I, II, or III
  • Meet the criteria for (active disease) at both screening and baseline visits by achieving all of the criteria below:
  • 6 or more painful/tender joints
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  • 6 or more swollen joints
  • Visual Analog Scale (VAS) for pain of at least 3 (on scale of 1-10, where 1 is mild)
  • C-reactive protein (CRP) greater than or equal to 0.6 mg/dl or ESR greater than 25 mm/hr.
  • Prior/Current Therapy:
  • Subjects must be either DMARD or biological anti-RA agent naive or have failed a DMARD/biological RA agent, other than sulfasalazine, and have stopped this DMARD/biological one (1) month prior to randomization unless they have a flare in disease activity upon discontinuing DMARD/biological therapy as part of this protocol. DMARDs include but are not limited to methotrexate, leflunomide, minocycline, hydroxychloroquine, gold, cyclosporine, and biologics include anti-TNF and anti-IL-1 agents.
  • Subjects may be taking NSAIDs, provided the dose and frequency have been stable for 30 days prior to randomization. However if the patient meets the flare criteria they can be enrolled even if they have not fulfilled the criteria of being on a stable dose of NSAIDs and steroids for 30 days prior to randomization. At the time of flare neither steroids nor NSAIDs can be increased.
  • Subjects may be taking corticosteroid therapy equivalent to prednisone less than or equal to 7.5 mg/day. This dose must be stable for at least 1 month prior to randomization. Subjects may not change the dose of their corticosteroid or receive intra-articular or intra-muscular injections of corticosteroids, within 1 month of randomization or during the study. Note section 9.3 of the protocol, Concomitant Medication, has been amended to read: If it is medically necessary a one joint steroid injection is acceptable. This must be noted on the CRF and the joint excluded from the joint count.
  • Subjects may not be taking other complementary and/or alternative medications for RA for the last 1-month prior to randomization.
  • Subjects must provide written informed consent prior to any study-related screening tests.

Who cannot join

  • Subjects with RA for less than six months duration, or onset before age 16 (JRA)
  • Clinically significant, uncontrolled concurrent neurological, hematological, renal, hepatic, endocrine, pulmonary, or cardiovascular disease
  • Subjects with evidence of an active clinically important cardiovascular disease as evidenced by an ECG at screening
  • Concomitant therapy or therapy within the last 30 days with another investigational drug
  • Subjects with screening laboratory values that deviate from the upper or lower limits of normal by greater that the percentages listed below:
  • Liver function tests: Total bilirubin above the upper limit of normal (ULN). AST, ALT, 1.5 X greater than ULN
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  • Hematology: Total white blood count (WBC) less than 3500mm3. Hemoglobin and hematocrit less than 10 g/dl or 30%, unless stable for at least 3 months), and platelet count less than 100K or greater than 750 K.
  • Renal function tests: BUN or creatinine greater than 1.2 X above the ULN
  • Urinalysis: On dipstick - Proteinuria / hematuria / leukocytes greater than trace.
  • Subjects with serological evidence of chronic hepatitis B (positive HbsAG) or hepatitis C (positive C Ab), HIV
  • Subjects with evidence of active peptic ulcer disease or who have a reliable positive history of gastrointestinal bleeding within the past five (5) years. Any recurrent or history of an intestinal disorder that may interfere with the proper absorption of the drug
  • Pregnant women or nursing mothers
  • Subjects who plan to donate blood or blood products during the study or within 30 days following the last study visit.
  • One re-screening to meet criterion 6.1.5 will be allowed. Multiple screenings, beyond one for failure to meet criterion 6.1.5 are not allowed (at either screening or baseline).
  • Abuse of alcohol or drugs. The subject should not consume more than 2 units of alcohol per day. (A unit of alcohol is considered: 12 oz of beer, 6 oz of wine or 1 oz of spirits). This is on a per day basis and not the average for the week.
  • Subjects with a sulfonamide allergy
  • Subjects who have known G6PD deficiency
  • Subjects who are unable or unwilling to follow the protocol
  • Recent major trauma or major surgery or serious infection
  • Subjects who started but left, or were dropped out of this study, for any reason (subjects who left or are dropped will not be replaced).

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
TwHF
Keywords
DMARD, Clinical Trial, Thunder God Vine, Chinese Herb, Rheumatoid Arthritis, RA
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TwHFDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2003 (estimated)
  2. Study startJun 2003
  3. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
157 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00062465
Sponsor's protocol ID
030208
Other IDs
03-AR-0208
Status last verified
Mar 2006
First submitted
5 Jun 2003
Last updated
4 Mar 2008
Results posted
No

Publications

  • Tao X, Cai JJ, Lipsky PE. The identity of immunosuppressive components of the ethyl acetate extract and chloroform methanol extract (T2) of Tripterygium wilfordii Hook. F. J Pharmacol Exp Ther. 1995 Mar;272(3):1305-12.

    PubMed 7891348

  • Tao X, Cush JJ, Garret M, Lipsky PE. A phase I study of ethyl acetate extract of the chinese antirheumatic herb Tripterygium wilfordii hook F in rheumatoid arthritis. J Rheumatol. 2001 Oct;28(10):2160-7.

    PubMed 11669150

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TwHF in people with Rheumatoid Arthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00062465, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.

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