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

Rheumatoid Arthritis Clinical Trial

Official title:

Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04136262
• Other study ID #: 2018YFC1705204
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 25, 2019
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Quan Jiang, M.D
• Phone: +8613901081632
• Email: doctorjq[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Tripterygium wilfordii Hook F (TwHF)
Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.
• Methotrexate
Oral methotrexate 10 mg per week for 24 weeks.

Other:
• Dummy Tripterygium wilfordii Hook F (TwHF)
Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.

Locations

Country	Name	City	State
China	Guang'anmen Hospital, China Academy of Chinese Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of ACR20	Percentage of Participants With American College of Rheumatology 20% (ACR20)	week 24
Secondary	Percentage of ACR50	Percentage of Participants With American College of Rheumatology 50% (ACR 50)	week 24
Secondary	Percentage of ACR70	Percentage of Participants With American College of Rheumatology 70% (ACR 70)	week 24
Secondary	RAMRIS score	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.	week 24
Secondary	Mean 24-week Change in Disease Activity Score Based on 28-Joint Count (DAS28)	Average difference between 24-week and Baseline DAS28	week 24
Secondary	Change From Baseline in Modified Total Sharp X-Ray Score at Week 24	Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease	week 24
Secondary	Patient Reported Outcomes (PRO)	Patient-Reported Outcomes Scale	week 24