Rheumatoid ArthritisPhase 4NCT05393050
Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis
A Phase 4 study testing Colquhounia Root Tablet and Methotrexate tablets in people with Rheumatoid Arthritis, run by Quan Jiang at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Colquhounia Root Tablet and Methotrexate tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jul 2022to Jun 2024
- Phase
- Phase 4
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100052
About this study
Official title: Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis：A Randomized Controlled Trial
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).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Colquhounia Root Tablet, Methotrexate tablets
- Keywords
- Rheumatoid Arthritis, Colquhounia Root Tablet, Methotrexate, 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.
Colquhounia Root TabletDrug
Colquhounia Root Tablet is a tripterygium preparation
Methotrexate tabletsDrug
Methotrexate is a drug used to treat rheumatoid arthritis
| Study group | Role | What they receive |
|---|---|---|
| Colquhounia Root Tablet plus methotrexate (MTX) | Active comparator | 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. Receives: Drug: Colquhounia Root Tablet; Drug: Methotrexate tablets |
| placedo of Colquhounia Root Tablet plus methotrexate (MTX) | Placebo comparator | 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. Receives: Drug: Methotrexate tablets |
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 (4)
Percentage of ACR50
Percentage of Participants With American College of Rheumatology 50% (ACR50)
Measured: week 24
Percentage of ACR70
Percentage of Participants With American College of Rheumatology 70% (ACR70)
Measured: week 24
DAS28-ESR
28-joint disease activity score
Measured: week 24
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.
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 posted26 May 2022
- Study startJul 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quan Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393050
- Sponsor's protocol ID
- 2022-001P6A01
- Status last verified
- Jul 2022
- First submitted
- 23 May 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis：A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05393050
- Acronym / sponsor ID
- 2022-001P6A01
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Colquhounia Root Tablet, Methotrexate, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Quan JiangUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 May 2022 (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 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).
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 |
|---|---|---|
| Colquhounia Root Tablet plus methotrexate (MTX) | Active comparator | Drug: Colquhounia Root Tablet, Drug: Methotrexate tabletsColquhounia 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 plus methotrexate (MTX) | Placebo comparator | Drug: Methotrexate tabletsplacedo 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. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| Colquhounia Root TabletColquhounia Root Tablet is a tripterygium preparation | Drug | Colquhounia Root Tablet plus methotrexate (MTX) |
| Methotrexate tabletsMethotrexate is a drug used to treat rheumatoid arthritis | Drug | Colquhounia Root Tablet plus methotrexate (MTX), placedo of Colquhounia Root Tablet plus methotrexate (MTX) |
Primary outcome
Percentage of ACR20
Time frame: week 24
Percentage of Participants With American College of Rheumatology 20% (ACR20)
4 secondary outcomes
Percentage of ACR50
Time frame: week 24
Percentage of ACR70
Time frame: week 24
DAS28-ESR
Time frame: week 24
Chinese Patient-reported Activity Index with RA scale (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 8 Jul 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colquhounia Root Tablet and Methotrexate tablets in people with Rheumatoid Arthritis, run by Quan Jiang 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 5 inclusion and 15 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 8 Jul 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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, 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 8 Jul 2022.