NCT04136262

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Nov 2019

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 25, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

October 21, 2019

Last Update Submit

March 18, 2022

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisTripterygium wilfordii Hook Fmethotrexatepostmenopausal womenrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Percentage of ACR20

    Percentage of Participants With American College of Rheumatology 20% (ACR20)

    week 24

Secondary Outcomes (6)

  • Percentage of ACR50

    week 24

  • Percentage of ACR70

    week 24

  • RAMRIS score

    week 24

  • Mean 24-week Change in Disease Activity Score Based on 28-Joint Count (DAS28)

    week 24

  • Change From Baseline in Modified Total Sharp X-Ray Score at Week 24

    week 24

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Drug: MethotrexateOther: Dummy Tripterygium wilfordii Hook F (TwHF)

Interventions

Tripterygium wilfordii Hook F (TwHF)DRUG

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

Also known as: DND Pharm
Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX)
MethotrexateDRUG

Oral methotrexate 10 mg per week for 24 weeks.

Also known as: XINYI Pharm
Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX)TwHF (dummy) plus MTX
Dummy Tripterygium wilfordii Hook F (TwHF)OTHER

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

TwHF (dummy) plus MTX

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Quan Jiang, M.D

    Guang' anmen hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Quan Jiang, M.D

CONTACT

+8613901081632doctorjq@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Guang'anmen Hospital

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 23, 2019

Study Start

November 25, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

CN(1)