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

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04136262

Collaborator

(none)

300

Enrollment

Location

Arms

36.2

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Tripterygium wilfordii Hook F (TwHF) Drug: Methotrexate Other: Dummy Tripterygium wilfordii Hook F (TwHF)	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 25, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX) Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.	Drug: Tripterygium wilfordii Hook F (TwHF) Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Other Names: DND Pharm Drug: Methotrexate Oral methotrexate 10 mg per week for 24 weeks. Other Names: XINYI Pharm
Placebo Comparator: TwHF (dummy) plus MTX Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.	Drug: Methotrexate Oral methotrexate 10 mg per week for 24 weeks. Other Names: XINYI Pharm Other: Dummy Tripterygium wilfordii Hook F (TwHF) Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.

Arm

Intervention/Treatment

Experimental: Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX)

Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.

Drug: Tripterygium wilfordii Hook F (TwHF)

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

Other Names:

DND Pharm

Drug: Methotrexate

Oral methotrexate 10 mg per week for 24 weeks.

Other Names:

XINYI Pharm

Placebo Comparator: TwHF (dummy) plus MTX

Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.

Drug: Methotrexate

Oral methotrexate 10 mg per week for 24 weeks.

Other Names:

XINYI Pharm

Other: Dummy Tripterygium wilfordii Hook F (TwHF)

Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.

Outcome Measures

Primary Outcome Measures

Percentage of ACR20 [week 24]
Percentage of Participants With American College of Rheumatology 20% (ACR20)

Secondary Outcome Measures

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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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;
diagnosed with RA as determined by meeting the 2010 ACR/EULAR classification criteria and having had RA for at least 6 weeks;
active disease at the time of enrollment as indicated by 28-joint Disease Activity Score (DAS28) greater than 3.2;
no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents.

Exclusion Criteria:

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