Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis

Phase 2

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Tripterygium wilfordii Hook F (TwHF); Other: Dummy Tripterygium wilfordii Hook F (TwHF); Drug: Methotrexate

• Registration Number: NCT04136262
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-23
• Study Start: 2019-11-25
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-22
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX)	Tripterygium wilfordii Hook F (TwHF)	Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.
TwHF (dummy) plus MTX	Dummy Tripterygium wilfordii Hook F (TwHF)	Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.
Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX)	Methotrexate	Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.
TwHF (dummy) plus MTX	Methotrexate	Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of ACR20	week 24	Percentage of Participants With American College of Rheumatology 20% (ACR20)

Secondary Outcome Measures

Name	Time	Method
Mean 24-week Change in Disease Activity Score Based on 28-Joint Count (DAS28)	week 24	Average difference between 24-week and Baseline DAS28
Change From Baseline in Modified Total Sharp X-Ray Score at Week 24	week 24	Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease
Patient Reported Outcomes (PRO)	week 24	Patient-Reported Outcomes Scale
Percentage of ACR50	week 24	Percentage of Participants With American College of Rheumatology 50% (ACR 50)
Percentage of ACR70	week 24	Percentage of Participants With American College of Rheumatology 70% (ACR 70)
RAMRIS score	week 24	To explore the structural efficacy of Tripterygium wilfordii Hook F (TwHF) on synovitis, osteitis, and joint erosions as measured by MRI in postmenopausal women with active RA using the change in the RAMRIS score from Baseline to Week 24.

Trial Locations

Locations (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China