NCT02885597

Brief Summary

The purpose of this study is to determine whether Juanbi Pill combined with methotrexate are effective in the treatment of 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
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2018

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

August 18, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
1.8 years until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

August 18, 2016

Last Update Submit

July 13, 2018

Conditions

Juanbi PillRheumatoid Arthritis

Keywords

Juanbi PillMethotrexateActiveRheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

  • Rate of ACR (American College Of Rheumatology) 50

    at 3 months

  • changes of The Disease Activity Score (DAS) 28

    from baseline to 3 months

  • changes of the van der Heijde modified Sharp score

    from baseline to 12 months

Secondary Outcomes (51)

  • changes of The Disease Activity Score (DAS) 28

    from baseline to 2 weeks

  • changes of The Disease Activity Score (DAS) 28

    from baseline to 1 month

  • changes of The Disease Activity Score (DAS) 28

    from baseline to 6 months

  • changes of The Disease Activity Score (DAS) 28

    from baseline to 12 months

  • Rate of ACR(American College Of Rheumatology)50

    at 2 weeks

  • +46 more secondary outcomes

Study Arms (2)

Juanbi group

EXPERIMENTAL

participants should administrate both Juanbi pill and Methotrexate

Drug: Juanbi pillDrug: Methotrexate

placebo group

PLACEBO COMPARATOR

participants should administrate both Juanbi pill placebo and Methotrexate

Drug: Juanbi pill placeboDrug: Methotrexate

Interventions

Juanbi pillDRUG

4g, twice a day, 3month, oral

Also known as: Experimental: Juanbi group
Juanbi group
Juanbi pill placeboDRUG

4g, twice a day, 3month, oral

Also known as: Placebo Comparator: placebo group
placebo group
MethotrexateDRUG

5mg, once a week, 3 month, oral

Also known as: Experimental: Juanbi group, Placebo Comparator: placebo group
Juanbi groupplacebo group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with rheumatoid arthritis (score more then 5 of ACR (American College Of Rheumatology) /EULAR (European League Against Rheumatism), 2009 )
  • moderate-to-severe disease activity (Disease Activity Score for 28-joint counts (DAS28) of more than 3.2
  • an onset of symptoms within 12 months before enrollment, no prior exposure to more than 10mg oral glucocorticoids or biologic agents
  • paid employment or unpaid but measurable work (e.g., caring for a family and home)

You may not qualify if:

  • combined with other disease such as adjuvant arthritis, lupus arthritis, osteoarthritis and et al.
  • abnormal liver and my kidney function
  • pregnancy or have a plan of pregnancy,breast feeding women
  • severe chronic or acute disease interfering with therapy attendance
  • alcohol or substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua Hospital, Shanghai University of TCM

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (2)

  • Jia QY, Wang YR, Sun DW, Mao JC, Xue L, Gu XH, Yu X, Piao XM, Xu H, Liang QQ. Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. Chin J Integr Med. 2025 Feb;31(2):99-107. doi: 10.1007/s11655-024-3768-7. Epub 2024 Dec 21.

    PMID: 39707138DERIVED

  • Wang Q, Wang YR, Jia QY, Liu L, Xu CQ, Wang XY, Yao M, Cui XJ, Shi Q, Wang YJ, Liang QQ. The efficacy of the traditional Chinese medicine Juanbi pill combined with methotrexate in active rheumatoid arthritis: study protocol for a randomized controlled trial. Trials. 2018 Mar 20;19(1):188. doi: 10.1186/s13063-018-2555-1.

    PMID: 29558967DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidMotor Activity

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Yongjun Wang, Doctor

CONTACT

86-189177763018yjwang8888@126.com

Qianqian Liang, Doctor

CONTACT

86-021-64875390

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
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 31, 2016

Study Start

July 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2020

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations

CN(1)