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NCT Number: NCT02818361

Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis

Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herb, is widely used in China for treating Rheumatoid Arthritis (RA), but limited only for elderly RA patients because of its reproductive system toxicity. The investigators are inspired by Chinese external therapy, an immemorial therapy for thousands of years, and take its advantage to make TwHF topically in order to get an effective and safe treatment for active RA patients.

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria.
  • Documented diagnosis of damp-heat syndrome according to Traditional Chinese Medicine.
  • Patients, men and women, must age from 18 to 65 years old.
  • Patients must have moderately active RA based on the criteria of the DAS-28 score from 3.2 to 5.1.
  • If patients are receiving Disease-modifying anti-rheumatic drugs (DMARDs), then the doses should have been kept stable for at least 12 weeks.
  • If patients are receiving non-steroidal anti-inflammatory drugs (NSAIDs) or orally Chinese herbal medicine, then the doses should have been kept stable for at least 4 weeks.

Exclusion criteria

  • Skin allergies or broken skin;
  • Taking TwHF agents, glucocorticoids and biological agents;
  • Female patients who are pregnant, breast-feeding or planed to be pregnant;
  • Subjects suffering serious hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular diseases, gastrointestinal problems or liver and renal failure.

Treatment and study plan

Topical tripterygium gel

Drug

Placebo Gel

Drug

Primary outcomes

  1. Twenty percent improvement in the American College of Rheumatology criteria

    Time frame: Week 8.

    a patient must have 20% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 20% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the Health Assessment Questionnaire (HAQ), and the erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) level.

  2. Twenty percent improvement in the American College of Rheumatology criteria

    Time frame: Week 4.

Secondary outcomes

  1. Fifty percent improvement in the American College of Rheumatology criteria

    Time frame: Week 4 and week 8.

    a patient must have 50% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 50% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the HAQ), and the ESR or CRP level.

  2. The changes of the 28-joint count Disease Activity Score (DAS28)

    Time frame: Week 4 and week 8.

  3. The changes of Visual Analogue Scale (VAS) pain score

    Time frame: Week 1, 2, 3, 4, 5, 6, 7, and 8.

  4. The change of knee synovitis classification as assessed by musculoskeletal ultrasound (MSUS)

    Time frame: Week 2, 4, and 8.

    Synovitis classification is specific as follows: 0 level, no doppler signal; level 1: three independent point or 2 successive or 1 and 2 in independent dot doppler signal; level 2: doppler signal < 50% of the synovial membrane area; level 3 doppler signal is the synovium in > 50% of the area.

  5. The change of knee synovial hyperplasia classification as assessed by MSUS

    Time frame: Week 2, 4, and 8.

    Synovial hyperplasia classification is specific as follows: 0 level, no synovial hyperplasia; level 1: synovial hyperplasia of mild, not more than bone surface high attachment; level 2: synovial hyperplasia more than bone surface high wire, but not more than the backbone; level 3: synovial hyperplasia more than bone surface peak wires, and extends along the backbone of the side.

  6. The change of knee articular cavity effusion as assessed by MSUS

    Time frame: Week 2, 4, and 8.

    Articular cavity effusion adopts binary evaluation, namely: 0: normal, 1: abnormal.

  7. The change of knee bone erosion classification as assessed by MSUS

    Time frame: Week 2, 4, and 8.

    Bone erosion classification adopts binary evaluation, namely: 0: normal, 1: abnormal.

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 29, 2016
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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