Clinical trial NCT04136262: Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis
Official title: Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
Tripterygium wilfordii Hook F
methotrexate
postmenopausal women
randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate whether Tripterygium wilfordii Hook F combined with methotrexate (MTX) might be better than MTX alone for postmenopausal women with active rheumatoid arthritis (RA).

Detailed description: To compare the efficacy and safety of Tripterygium wilfordii Hook F (TwHF) and methotrexate (MTX) for postmenopausal women with active rheumatoid arthritis (RA), a multicenter, randomized controlled trial will be conducted. Three hundred postmenopausal women with active RA will be randomly allocated (1:1) to treatment with TwHF 20mg thrice daily and MTX 10 mg once a week for 24 weeks, or MTX plus dummy TwHF. The primary outcome is the percentage of participants with American College of Rheumatology 20% at week 24.

Eligibility criteria: Inclusion Criteria:

1. postmenopausal women, postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy;
2. diagnosed with RA as determined by meeting the 2010 ACR/EULAR classification criteria and having had RA for at least 6 weeks;
3. active disease at the time of enrollment as indicated by 28-joint Disease Activity Score (DAS28) greater than 3.2;
4. no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents.

Exclusion Criteria:

1. RA combined with other autoimmune disease, such as adjuvant arthritis, lupus arthritis, or osteoarthritis;
2. RA combined with abnormal liver and kidney function;
3. severe chronic or acute disease interfering with attendance for therapy;
4. patients who had received DMARDs or biological therapy within one months before participating in this study.

Primary outcomes:
measure: Percentage of ACR20
timeFrame: week 24
Secondary outcomes:
measure: Percentage of ACR50
timeFrame: week 24
measure: Percentage of ACR70
timeFrame: week 24
measure: RAMRIS score
timeFrame: week 24
measure: Mean 24-week Change in Disease Activity Score Based on 28-Joint Count (DAS28)
timeFrame: week 24
measure: Change From Baseline in Modified Total Sharp X-Ray Score at Week 24
timeFrame: week 24
measure: Patient Reported Outcomes (PRO)
timeFrame: week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Study officials:
affiliation: Guang' anmen hospital
name: Quan Jiang, M.D
role: PRINCIPAL_INVESTIGATOR
References: