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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tripterygium wilfordii Hook F (TwHF); Other: Dummy Tripterygium wilfordii Hook F (TwHF); Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT04136262

2018YFC1705204

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: Methotrexate

Drug: Tripterygium wilfordii Hook F (TwHF)

TwHF (dummy) plus MTX

Placebo Comparator group

Description:

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

Treatment:

Other: Dummy Tripterygium wilfordii Hook F (TwHF)

Drug: Methotrexate