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Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Not yet recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Colquhounia Root Tablet

Methotrexate tablets

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Colquhounia Root Tablet, Methotrexate, Randomized controlled trial

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject understood the whole process of the trial and signed the informed consent voluntarily.
Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.
Subjects aged between 45-70years who were the males without fertility requirements or menopausal women.
Subject has a DAS28 CRP disease activity score greater than 2.6 and less than 5.1.
Subject did not participate in any drug trials within 1 month before enrollment.

Exclusion Criteria:

Pregnant women, women planning to become pregnant or breastfeeding.
Severe systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, autoimmune liver disease.
Active liver disease or abnormal liver function, ALT and AST are more than 1.5 times the upper limit of normal.
Renal impairment, serum creatinine greater than the upper limit of normal.
Bone marrow hematopoietic dysfunction, peripheral blood leukocytes <3.0×109/L, or definite anemia (hemoglobin less than 80g/L), or platelets <80×109/L, or other blood system diseases.
Active gastric and duodenal ulcers.
Uncontrolled severe hypertension, metabolic diseases.
malignant tumors.
Acute and/or chronic infectious diseases.
Severe cardiac arrhythmia found on electrocardiogram.
Mental illness, history of alcoholism, drug or other substance abuse.
Diagnosed with other connective tissue disease.
Those who have used immunosuppressants, biological agents, Colquhounia Root Tablet or drugs containing Tripterygium wilfordii within 1 month before enrollment.
Those who have previously used methotrexate or preparations containing tripterygium wilfordii for 12 weeks or more ,but their condition is not under control.
Adverse reactions have occurred in the past using Colquhounia Root Tablet or drugs containing Tripterygium wilfordii.

Sites / Locations

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Colquhounia Root Tablet plus methotrexate (MTX)

placedo of Colquhounia Root Tablet plus methotrexate (MTX)

Arm Description

Colquhounia Root Tablet 0.9g tid and methotrexate (MTX) 10 mg oncea week for the first 12 weeks，Colquhounia Root Tablet 0.54g tid and methotrexate (MTX) 10 mg once a week for the after 12 weeks.

placedo of Colquhounia Root Tablet 0.9g tid and methotrexate (MTX) 10 mg oncea week for the first 12 weeks，placedo of Colquhounia Root Tablet 0.54g tid and methotrexate (MTX) 10 mg once a week for the after 12 weeks.

Outcomes

Primary Outcome Measures

Percentage of ACR20

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

Secondary Outcome Measures

Percentage of ACR50

Percentage of Participants With American College of Rheumatology 50% (ACR50)

Percentage of ACR70

Percentage of Participants With American College of Rheumatology 70% (ACR70)

DAS28-ESR

28-joint disease activity score

Chinese Patient-reported Activity Index with RA scale (PRO)

Patient-Reported Outcomes Scale,The self-rating scale consists of 12 items,Each item was rated 0, 1, 2 and 3 on the scale of asymptomatic to aggravating symptoms, respectively.

Full Information

NCT ID

NCT05393050

First Posted

May 23, 2022

Last Updated

July 6, 2022

Sponsor

Quan Jiang

1. Study Identification

Unique Protocol Identification Number

NCT05393050

Brief Title

Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis

Official Title

Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis：A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 2022 (Anticipated)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Quan Jiang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate whether Colquhounia Root Tablet combined with methotrexate (MTX) might be better than MTX alone for patients with active rheumatoid arthritis (RA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Colquhounia Root Tablet, Methotrexate, Randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Colquhounia Root Tablet plus methotrexate (MTX)

Arm Type

Active Comparator

Arm Description

Colquhounia Root Tablet 0.9g tid and methotrexate (MTX) 10 mg oncea week for the first 12 weeks，Colquhounia Root Tablet 0.54g tid and methotrexate (MTX) 10 mg once a week for the after 12 weeks.

Arm Title

placedo of Colquhounia Root Tablet plus methotrexate (MTX)

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Colquhounia Root Tablet

Intervention Description

Colquhounia Root Tablet is a tripterygium preparation

Intervention Type

Drug

Intervention Name(s)

Methotrexate tablets

Intervention Description

Methotrexate is a drug used to treat rheumatoid arthritis

Primary Outcome Measure Information:

Title

Percentage of ACR20

Description

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

Time Frame

week 24

Secondary Outcome Measure Information:

Title

Percentage of ACR50

Description

Percentage of Participants With American College of Rheumatology 50% (ACR50)

Time Frame

week 24

Title

Percentage of ACR70

Description

Percentage of Participants With American College of Rheumatology 70% (ACR70)

Time Frame

week 24

Title

DAS28-ESR

Description

28-joint disease activity score

Time Frame

week 24

Title

Chinese Patient-reported Activity Index with RA scale (PRO)

Description

Patient-Reported Outcomes Scale,The self-rating scale consists of 12 items,Each item was rated 0, 1, 2 and 3 on the scale of asymptomatic to aggravating symptoms, respectively.

Time Frame

week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject understood the whole process of the trial and signed the informed consent voluntarily. Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria. Subjects aged between 45-70years who were the males without fertility requirements or menopausal women. Subject has a DAS28 CRP disease activity score greater than 2.6 and less than 5.1. Subject did not participate in any drug trials within 1 month before enrollment. Exclusion Criteria: Pregnant women, women planning to become pregnant or breastfeeding. Severe systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, autoimmune liver disease. Active liver disease or abnormal liver function, ALT and AST are more than 1.5 times the upper limit of normal. Renal impairment, serum creatinine greater than the upper limit of normal. Bone marrow hematopoietic dysfunction, peripheral blood leukocytes <3.0×109/L, or definite anemia (hemoglobin less than 80g/L), or platelets <80×109/L, or other blood system diseases. Active gastric and duodenal ulcers. Uncontrolled severe hypertension, metabolic diseases. malignant tumors. Acute and/or chronic infectious diseases. Severe cardiac arrhythmia found on electrocardiogram. Mental illness, history of alcoholism, drug or other substance abuse. Diagnosed with other connective tissue disease. Those who have used immunosuppressants, biological agents, Colquhounia Root Tablet or drugs containing Tripterygium wilfordii within 1 month before enrollment. Those who have previously used methotrexate or preparations containing tripterygium wilfordii for 12 weeks or more ,but their condition is not under control. Adverse reactions have occurred in the past using Colquhounia Root Tablet or drugs containing Tripterygium wilfordii.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Quan Jiang, M.D

Phone

+8613901081632

doctorjq@126.com

Facility Information:

Facility Name

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100052

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis

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