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Completed

NCT Number: NCT01613079

Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

Evaluation of oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of RA patients with clinical efficacy and safety.Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.

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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

Phase 2 / Phase 3

Primary location

Deptment of Rheumatology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-65 years with informed consent
  • Diagnosed with rheumatoid arthritis as determined by meeting the 2010 ACR/EULAR classification criteria and has had rheumatoid arthritis for at least 6 weeks
  • Swollen joint (SJC)≥3 and tender joint count(TJC)≥5
  • ESR >28 mm/hr or C-reactive protein > 20 mg/L

Exclusion criteria

  • Pregnant, lactating or further fertility requirements
  • Previous treated with methotrexate or biologic DMARD.
  • Active or chronic infection, including HIV, HCV, HBV, tuberculosis
  • Patient with cancer

Treatment and study plan

Tripterygium wilfordii Hook F

Drug

Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.

methotrexate

Drug

Oral methotrexate 7.5-12.5mg per week for 24 weeks. The starting dose was 7.5mg per week, then increased to 12.5mg（max 0.3mg/Kg） per week in 4 weeks. Folic acid at the dose of 10mg per week were applied to all patients.

Primary outcomes

  1. ACR50

    Time frame: 24 weeks.

    The proportion of patients achieving ACR50.

Secondary outcomes

  1. Radiology outcome

    Time frame: 24 weeks

    The change in X-Ray from baseline to week 24.

  2. DAS28

    Time frame: 24 weeks

    The change in DAS score from baseline to week 24.

  3. ACR20/70

    Time frame: 24 weeks

    The proportion of patients achieving ACR20 & ACR70.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Evaluation of Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of RA Patients With Clinical Efficacy and Safety.

Acronym: TRIFRA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 6, 2012
Registry last updated
Aug 5, 2013

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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