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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03324412 |
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Date of registration:
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25/10/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis
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Scientific title:
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A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of TwHF and MTX Treating Rheumatoid Arthritis |
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Date of first enrolment:
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October 28, 2017 |
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Target sample size:
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216 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03324412 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2/Phase 3
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Contacts
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Name:
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Jiang Quan, MD |
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Address:
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Telephone:
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010-88001060 |
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Email:
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doctor@126.com |
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Affiliation:
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Name:
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Jiang Quan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Age minimum:
45 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Treatment of MTX
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Drug: Treatment of MTX and TwHF
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Primary Outcome(s)
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The change from Baseline to week 24 in Disease Activity Score (DAS28)
[Time Frame: 0 weeks, 4 weeks,12 weeks, 24 weeks,52 weeks]
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Secondary Outcome(s)
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The number of adverse events
[Time Frame: 24 weeks]
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The change in Sharp score
[Time Frame: 0 week,24 weeks,52 weeks]
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The proportion of patients achieving ACR20/50/70
[Time Frame: 0 weeks, 4 weeks,12 weeks, 24 weeks]
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The change in Health Assessment Questionnaire (HAQ) score
[Time Frame: 0 weeks, 4 weeks,12 weeks, 24 weeks,52 weeks]
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Secondary ID(s)
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Z161100000516020-2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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