Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or Sulfasalazine

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00062465
• Date of registration: 05/06/2003
• Prospective Registration: No
• Primary sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Public title: Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or Sulfasalazine
• Scientific 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
• Date of first enrolment: June 2003
• Target sample size: 157
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00062465
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

INCLUSION CRITERIA

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

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:

A. 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.

B. 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.

C. 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.

D. 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.

EXCLUSION CRITERIA

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

- 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).



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: TwHF

Secondary ID(s)

030208

03-AR-0208

Source(s) of Monetary Support

Please refer to primary and secondary sponsors