Rheumatoid ArthritisPhase 2/3NCT03337815
A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis
A Phase 2/3 study of Rheumatoid Arthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium Wilfordii has effects of anti-inflammatory, immunosuppressive and cartilage protection. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2017to 30 Sep 2019
- Phase
- Phase 2/3
- 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
- Diagnosed with rheumatoid arthritis as determined by the 1987 or 2010 ACR classification criteria;
- No male or female fertility requirements, or around menopause women;
- Patients with mild-to-moderate activity, 2.6 < DAS28≤5.1;
- No serious system involved, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, etc;
- Within a month before the selected participants did not attend any drugs
Who cannot join
- 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 Tripterygium Wilfordii or MTX
- Patients with retinopathy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital
Beijing, Beijing Municipality, 100053
Quan Jiang, +8688001060, doctorjq@126.com
About this study
Official title: A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of Tripterygium Wilfordii Treating Rheumatoid Arthritis and Establish A Prediction Model
Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium Wilfordii has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a multicenter ,double Blind, randomized study to evaluated the efficacy and safety of Tripterygium Wilfordii in treating of patients with rheumatoid arthritis (RA) and establish a prediction model for Tripterygium Wilfordii response of rheumatoid arthritis (RA).
Read the detailed description
Two arms were included in this study. Active Comparator: Patients were treated with Methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.Experimental:Patients were treated with Methotrexate (MTX) placebo and Tripterygium wilfordii Hook F（TwHF)
- Conditions
- Rheumatoid Arthritis
- Being tested
- Treatment of MTX and TwHF placebo, Treatment of TwHF and MTX placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of MTX and TwHF placeboDrug
Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.Tripterygium wilfordii Hook F（TwHF）placebo：20mg,3 times a day, oral, for 24 weeks.
Treatment of TwHF and MTX placeboDrug
Tripterygium wilfordii Hook F（TwHF)：20mg,3 times a day, oral, for 24 weeks.Methotrexate (MTX)placebo: 10-15mg per week according to patient's weight, oral, for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of MTX and TwHF placebo | Active comparator | Patients were treated with Methotrexate (MTX) and Tripterygium wilfordii Hook F（TwHF）placebo. Receives: Drug: Treatment of MTX and TwHF placebo |
| Treatment of TwHF and MTX placebo | Experimental | Patients were treated with Tripterygium wilfordii Hook F（TwHF）and Methotrexate (MTX) placebo. Receives: Drug: Treatment of TwHF and MTX placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Disease Activity Score (DAS28)
Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4[ESR])
Measured: 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks
Secondary outcomes (4)
The proportion of patients achieving ACR20/50/70
ACR20/50/70 is referred to American College of Rheumatology Criteria
Measured: 0 weeks, 4 weeks，12 weeks, 24 weeks
The change in Health Assessment Questionnaire (HAQ) score
HAQ scores ranges from 0 to 3, with higher scores indicating greater disability
Measured: 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks
The change in Sharp scoring system of van der Heijde(Sharp) score
The change in Sharp score from baseline to week 24 and 52.According to the revised Sharp scoring system of van der Heijde, the joint gap score was scored in 30 regions of the hands (score range 0-120 points), and the bone erosion score was conducted in 32 areas (score range 0-160).The higher the score, the more serious the joint destruction.
Measured: 0 week,24 weeks,52 weeks
The number of adverse events
The number of adverse events that are related to treatment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start28 Oct 2017
- Primary completion31 Mar 2019 (estimated)
- Study completion30 Sep 2019 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jiang Quan, MD, Study director, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337815
- Sponsor's protocol ID
- Z161100000516020-1
- Status last verified
- Nov 2017
- First submitted
- 22 Oct 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of Tripterygium Wilfordii Treating Rheumatoid Arthritis and Establish A Prediction Model
- ClinicalTrials.gov ID
- NCT03337815
- Acronym / sponsor ID
- Z161100000516020-1
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 28 Oct 2017 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 9 Nov 2017 (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.
Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium Wilfordii has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a multicenter ,double Blind, randomized study to evaluated the efficacy and safety of Tripterygium Wilfordii in treating of patients with rheumatoid arthritis (RA) and establish a prediction model for Tripterygium Wilfordii response of rheumatoid arthritis (RA).
Detailed description
Two arms were included in this study. Active Comparator: Patients were treated with Methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.Experimental:Patients were treated with Methotrexate (MTX) placebo and Tripterygium wilfordii Hook F（TwHF)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment of MTX and TwHF placebo | Active comparator | Drug: Treatment of MTX and TwHF placeboPatients were treated with Methotrexate (MTX) and Tripterygium wilfordii Hook F（TwHF）placebo. |
| Treatment of TwHF and MTX placebo | Experimental | Drug: Treatment of TwHF and MTX placeboPatients were treated with Tripterygium wilfordii Hook F（TwHF）and Methotrexate (MTX) placebo. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with rheumatoid arthritis as determined by the 1987 or 2010 ACR classification criteria;
- No male or female fertility requirements, or around menopause women;
- Patients with mild-to-moderate activity, 2.6 < DAS28≤5.1;
- No serious system involved, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, etc;
- Within a month before the selected participants did not attend any drugs
Key exclusion criteria (5 listed)
- 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 Tripterygium Wilfordii or MTX
- Patients with retinopathy.
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 |
|---|---|---|
| Treatment of MTX and TwHF placeboMethotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.Tripterygium wilfordii Hook F（TwHF）placebo：20mg,3 times a day, oral, for 24 weeks. | Drug | Treatment of MTX and TwHF placebo |
| Treatment of TwHF and MTX placeboTripterygium wilfordii Hook F（TwHF)：20mg,3 times a day, oral, for 24 weeks.Methotrexate (MTX)placebo: 10-15mg per week according to patient's weight, oral, for 24 weeks. | Drug | Treatment of TwHF and MTX placebo |
Primary outcome
The change in Disease Activity Score (DAS28)
Time frame: 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks
Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4[ESR])
4 secondary outcomes
The proportion of patients achieving ACR20/50/70
Time frame: 0 weeks, 4 weeks，12 weeks, 24 weeks
The change in Health Assessment Questionnaire (HAQ) score
Time frame: 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks
The change in Sharp scoring system of van der Heijde(Sharp) score
Time frame: 0 week,24 weeks,52 weeks
The number of adverse events
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Jiang Quan, MD study director
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study of Rheumatoid Arthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences 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 5 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 9 Nov 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jiang Quan, MD (010-88001060, doctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Disease Activity Score (DAS28) (time frame: 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks). 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 9 Nov 2017.