NCT02551575

Brief Summary

This is prospective randomized, controlled study to evaluate the efficacy and safety of Qingre Huoxue comprehensive therapy in treating of patients with early Rheumatoid Arthritis (RA). The major outcome index is the change from baseline to week 24 in Disease Activity Score (DAS28), and minor outcome indexes include American College of Rheumatology (ACR)20/50/70, PRO score, Sharp score and OMERACT RAMRIS score. The adverse events at any time were recorded to evaluate the safety.

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
468

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Nov 2014

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

Study Start

First participant enrolled

November 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

2.6 years

First QC Date

August 26, 2015

Last Update Submit

June 17, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • The change from Baseline to week 24 in Disease Activity Score (DAS28)

    Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4\[ESR\])

    0 weeks, 12 weeks, 24 weeks

Secondary Outcomes (5)

  • The proportion of patients achieving ACR20/50/70

    0 week, 12 weeks, 24 weeks

  • The change from baseline to week 24 in the score on the patient report outcome (PRO)

    0 week, 12 weeks, 24 weeks

  • The change in Sharp score

    0 week, 52 weeks

  • The change in OMERACT RAMRIS score

    0 week, 24 weeks

  • The number of adverse events

    24 weeks

Study Arms (3)

Treatment of MTX and HCQ

ACTIVE COMPARATOR

Patients were treated with methotrexate (MTX), hydroxychloroquine (HCQ), oral Qingre Huoxue granule placebo and Qingre Huoxue external preparation placebo.

Drug: Treatment of MTX and HCQ

Treatment of TCM

EXPERIMENTAL

Patients were treated with oral Qingre Huoxue granule, Qingre Huoxue external preparation, methotrexate placebo and hydroxychloroquine placebo.

Drug: Treatment of TCM

Integrative Medicine

EXPERIMENTAL

The patients were treated with methotrexate, hydroxychloroquine, oral Qingre Huoxue granule and Qingre Huoxue external preparation.

Drug: Integrative Medicine

Interventions

Treatment of MTX and HCQDRUG

Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks. Hydroxychloroquine: 200mg, 2 times a day, oral, for 24 weeks. Qingre Huoxue granule placebo: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation placebo: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks.

Also known as: Treatment of MTX, HCQ and Qingre Huoxue placebo
Treatment of MTX and HCQ
Treatment of TCMDRUG

Qingre Huoxue granule: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks. Methotrexate placebo: 10-15mg per week according to patient's weight, oral, for 24 weeks. Hydroxychloroquine placebo: 200mg, 3 times a day, oral, for 24 weeks.

Also known as: Qingre Huoxue medicines，MTX placebo and HCQ placebo
Treatment of TCM
Integrative MedicineDRUG

Qingre Huoxue granule: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks. Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks. Hydroxychloroquine: 200mg, 3 times a day, oral, for 24 weeks.

Also known as: Treatment of Qingre Huoxue medicines，MTX and HCQ
Integrative Medicine

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with rheumatoid arthritis as determined by the 1987 ACR classification criteria.
  • Diagnosed with TCM dampness heat and blood stasis syndrome
  • The course of RA is not more than 5 years.
  • Swollen joint (SJC)≥2 and tender joint count(TJC)≥3.
  • Erythrocyte Sedimentation Rate（ESR）≥20 mm/hr
  • Patients who take disease-modifying antirheumatic drugs for at least 3 months on a stable dose, and retain the same treatment during the study.
  • Age 18-65 years with informed consent

You may not qualify if:

  • Patients with skin burst or allergies.
  • Patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath
  • Active or chronic infection, including HIV, hepatitis C virus, hepatitis B virus, tuberculosis
  • Previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (DMARD) in 3 months.
  • Previous treated with MTX or HCQ
  • Patients with retinopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, 100052, China

Location

Related Publications (1)

  • Gong X, Liu WX, Tang XP, Wang J, Liu J, Huang QC, Liu W, Fang YF, He DY, Liu Y, Gao ML, Wu QJ, Chen S, Li ZB, Wang Y, Xie YM, Zhang JL, Zhou CY, Ma L, Wang XC, Zhang C, Jiang Q. Traditional Chinese Medicine Qingre Huoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis: A Multicenter, Double-Blind, Randomized Controlled Trial. Front Pharmacol. 2021 May 25;12:679588. doi: 10.3389/fphar.2021.679588. eCollection 2021.

    PMID: 34113254DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jiang Quan, MD

    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director，Devision of Rheumatology

Study Record Dates

First Submitted

August 26, 2015

First Posted

September 16, 2015

Study Start

November 1, 2014

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

June 20, 2016

Record last verified: 2016-06

Locations

CN(1)