Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04136262
Recruitment Status : Unknown
Verified December 2019 by Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  Recruiting
First Posted : October 23, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Quan Jiang, 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).

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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 Name: DND Pharm

Drug: Methotrexate
Oral methotrexate 10 mg per week for 24 weeks.
Other Name: 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 Name: XINYI Pharm

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




Primary Outcome Measures :
  1. Percentage of ACR20 [ Time Frame: week 24 ]
    Percentage of Participants With American College of Rheumatology 20% (ACR20)


Secondary Outcome Measures :
  1. Percentage of ACR50 [ Time Frame: week 24 ]
    Percentage of Participants With American College of Rheumatology 50% (ACR 50)

  2. Percentage of ACR70 [ Time Frame: week 24 ]
    Percentage of Participants With American College of Rheumatology 70% (ACR 70)

  3. RAMRIS score [ Time Frame: 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.

  4. Mean 24-week Change in Disease Activity Score Based on 28-Joint Count (DAS28) [ Time Frame: week 24 ]
    Average difference between 24-week and Baseline DAS28

  5. Change From Baseline in Modified Total Sharp X-Ray Score at Week 24 [ Time Frame: week 24 ]
    Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease

  6. Patient Reported Outcomes (PRO) [ Time Frame: week 24 ]
    Patient-Reported Outcomes Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136262


Contacts
Layout table for location contacts
Contact: Quan Jiang, M.D +8613901081632 ext 0 doctorjq@126.com

Locations
Layout table for location information
China
Guang'anmen Hospital, China Academy of Chinese Medical Sciences Recruiting
Beijing, China, 100053
Contact: Quan Jiang, M.D         
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
Layout table for investigator information
Principal Investigator: Quan Jiang, M.D Guang' anmen hospital
Layout table for additonal information
Responsible Party: Quan Jiang, Guang'anmen Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT04136262    
Other Study ID Numbers: 2018YFC1705204
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
rheumatoid arthritis
Tripterygium wilfordii Hook F
methotrexate
postmenopausal women
randomized controlled trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors