Rheumatoid ArthritisPhase 2/3NCT04136262
Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis
A Phase 2/3 study testing Tripterygium wilfordii Hook F (TwHF), Methotrexate and Dummy Tripterygium wilfordii Hook F (TwHF) in people with Rheumatoid Arthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tripterygium wilfordii Hook F (TwHF), Methotrexate and Dummy Tripterygium wilfordii Hook F (TwHF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2019to Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, 100053
Quan Jiang, M.D
About this study
Official title: Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled Trial
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).
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tripterygium wilfordii Hook F (TwHF), Methotrexate, Dummy Tripterygium wilfordii Hook F (TwHF)
- Keywords
- rheumatoid arthritis, Tripterygium wilfordii Hook F, methotrexate, postmenopausal women, randomized controlled trial
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tripterygium wilfordii Hook F (TwHF)Drug
Also called DND Pharm
Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.
MethotrexateDrug
Also called XINYI Pharm
Oral methotrexate 10 mg per week for 24 weeks.
Dummy Tripterygium wilfordii Hook F (TwHF)Other
Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX) | Experimental | Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks. Receives: Drug: Tripterygium wilfordii Hook F (TwHF); Drug: Methotrexate |
| TwHF (dummy) plus MTX | Placebo comparator | Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks. Receives: Drug: Methotrexate; Other: Dummy Tripterygium wilfordii Hook F (TwHF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of ACR20
Percentage of Participants With American College of Rheumatology 20% (ACR20)
Measured: week 24
Secondary outcomes (6)
Percentage of ACR50
Percentage of Participants With American College of Rheumatology 50% (ACR 50)
Measured: week 24
Percentage of ACR70
Percentage of Participants With American College of Rheumatology 70% (ACR 70)
Measured: week 24
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.
Measured: week 24
Mean 24-week Change in Disease Activity Score Based on 28-Joint Count (DAS28)
Average difference between 24-week and Baseline DAS28
Measured: week 24
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
Measured: week 24
Patient Reported Outcomes (PRO)
Patient-Reported Outcomes Scale
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start25 Nov 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Quan Jiang, M.D, Principal investigator, Guang' anmen hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136262
- Sponsor's protocol ID
- 2018YFC1705204
- Status last verified
- Mar 2022
- First submitted
- 21 Oct 2019
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04136262
- Acronym / sponsor ID
- 2018YFC1705204
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, Tripterygium wilfordii Hook F, methotrexate, postmenopausal women, randomized controlled trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX) | Experimental | Drug: Tripterygium wilfordii Hook F (TwHF), Drug: MethotrexateOral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks. |
| TwHF (dummy) plus MTX | Placebo comparator | Drug: Methotrexate, Other: Dummy Tripterygium wilfordii Hook F (TwHF)Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tripterygium wilfordii Hook F (TwHF)Also: DND PharmOral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. | Drug | Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX) |
| MethotrexateAlso: XINYI PharmOral methotrexate 10 mg per week for 24 weeks. | Drug | Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX), TwHF (dummy) plus MTX |
| Dummy Tripterygium wilfordii Hook F (TwHF)Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. | Other | TwHF (dummy) plus MTX |
Primary outcome
Percentage of ACR20
Time frame: week 24
Percentage of Participants With American College of Rheumatology 20% (ACR20)
6 secondary outcomes
Percentage of ACR50
Time frame: week 24
Percentage of ACR70
Time frame: week 24
RAMRIS score
Time frame: week 24
Mean 24-week Change in Disease Activity Score Based on 28-Joint Count (DAS28)
Time frame: week 24
Change From Baseline in Modified Total Sharp X-Ray Score at Week 24
Time frame: week 24
Patient Reported Outcomes (PRO)
Time frame: week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quan Jiang, M.D principal investigator
Guang' anmen hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tripterygium wilfordii Hook F (TwHF), Methotrexate and Dummy Tripterygium wilfordii Hook F (TwHF) in people with Rheumatoid Arthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quan Jiang, M.D (+8613901081632 ext. 0, doctorjq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of ACR20 (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.