Back to resultsTripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tripterygium wilfordii Hook F (TwHF)
Methotrexate
Dummy Tripterygium wilfordii Hook F (TwHF)
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, Tripterygium wilfordii Hook F, methotrexate, postmenopausal women, randomized controlled trial
Eligibility Criteria
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.
Sites / Locations
- Guang'anmen Hospital, China Academy of Chinese Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX)
TwHF (dummy) plus MTX
Arm Description
Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.
Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.
Outcomes
Primary Outcome Measures
Percentage of ACR20
Percentage of Participants With American College of Rheumatology 20% (ACR20)
Secondary Outcome Measures
Percentage of ACR50
Percentage of Participants With American College of Rheumatology 50% (ACR 50)
Percentage of ACR70
Percentage of Participants With American College of Rheumatology 70% (ACR 70)
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.
Mean 24-week Change in Disease Activity Score Based on 28-Joint Count (DAS28)
Average difference between 24-week and Baseline DAS28
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
Patient Reported Outcomes (PRO)
Patient-Reported Outcomes Scale
Full Information
NCT ID
NCT04136262
First Posted
October 21, 2019
Last Updated
March 18, 2022
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04136262
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, Tripterygium wilfordii Hook F, methotrexate, postmenopausal women, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX)
Arm Type
Experimental
Arm Description
Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.
Arm Title
TwHF (dummy) plus MTX
Arm Type
Placebo Comparator
Arm Description
Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Tripterygium wilfordii Hook F (TwHF)
Other Intervention Name(s)
DND Pharm
Intervention Description
Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
XINYI Pharm
Intervention Description
Oral methotrexate 10 mg per week for 24 weeks.
Intervention Type
Other
Intervention Name(s)
Dummy Tripterygium wilfordii Hook F (TwHF)
Intervention Description
Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.
Primary Outcome Measure Information:
Title
Percentage of ACR20
Description
Percentage of Participants With American College of Rheumatology 20% (ACR20)
Time Frame
week 24
Secondary Outcome Measure Information:
Title
Percentage of ACR50
Description
Percentage of Participants With American College of Rheumatology 50% (ACR 50)
Time Frame
week 24
Title
Percentage of ACR70
Description
Percentage of Participants With American College of Rheumatology 70% (ACR 70)
Time Frame
week 24
Title
RAMRIS score
Description
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.
Time Frame
week 24
Title
Mean 24-week Change in Disease Activity Score Based on 28-Joint Count (DAS28)
Description
Average difference between 24-week and Baseline DAS28
Time Frame
week 24
Title
Change From Baseline in Modified Total Sharp X-Ray Score at Week 24
Description
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease
Time Frame
week 24
Title
Patient Reported Outcomes (PRO)
Description
Patient-Reported Outcomes Scale
Time Frame
week 24
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quan Jiang, M.D
Phone
+8613901081632
Ext
0
Email
doctorjq@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quan Jiang, M.D
Organizational Affiliation
Guang' anmen hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quan Jiang, M.D
12. IPD Sharing Statement
Learn more about this trial
Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis
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