Clinical trial NCT03324412: Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis
Official title: A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of TwHF and MTX Treating Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 216
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium Wilfordii has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a multicenter ,double Blind, randomized study to evaluated the efficacy and safety of Tripterygium Wilfordii in treating of patients with rheumatoid arthritis (RA) and establish a prediction model for Tripterygium Wilfordii response of rheumatoid arthritis (RA).

Detailed description: Two arms were included in this study. Active Comparator: treatment of MTX Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.Experimental: treatment of TwHF Patients were treated with methotrexate (MTX) and Tripterygium wilfordii Hook F（TwHF).

Eligibility criteria: Inclusion Criteria:

* Diagnosed with rheumatoid arthritis as determined by the 1987 or 2010 ACR classification criteria;
* No male or female fertility requirements, or around menopause women;
* Patients with mild-to-moderate activity, 2.6 \< DAS28≤5.1;
* No serious system involved, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, etc;
* Within a month before the selected participants did not attend any drugs

Exclusion Criteria:

* Patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath
* Active or chronic infection, including HIV, hepatitis C virus, hepatitis B virus, tuberculosis
* Previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (DMARD) in 3 months.
* Previous treated with Tripterygium Wilfordii or MTX
* Patients with retinopathy.

Primary outcomes:
measure: The change from Baseline to week 24 in Disease Activity Score (DAS28)
timeFrame: 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks
Secondary outcomes:
measure: The proportion of patients achieving ACR20/50/70
timeFrame: 0 weeks, 4 weeks，12 weeks, 24 weeks
measure: The change in Health Assessment Questionnaire (HAQ) score
timeFrame: 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks
measure: The change in Sharp score
timeFrame: 0 week,24 weeks,52 weeks
measure: The number of adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Jiang Quan, MD
role: STUDY_DIRECTOR
References: