Rheumatoid Arthritis of Knee Clinical Trial
Official title:
The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee
Verified date | July 2017 |
Source | Chinese PLA General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim: Comparing the efficacy and safety of intra-articular injection of tocilizumab and
compound betamethasone.
Study design: A randomized, single-blind, parallel controlled and one center trial design.
Sample size: 60 cases. Study content: Patients who meet inclusive criteria will be randomly
divided into tocilizumab group and compound betamethasone group. In the baseline period, the
investigators will collect patients' general information, disease information, disease
activity score, laboratory results and images of articular ultrasound. After 4 weeks of
injection, patients will be asked to come back, and their disease information, disease
activity score, laboratory results as well as images of articular ultrasound will be
collected. Finally, these data will be sorted and analyzed.
Hypothesis: The efficacy and safety of intra-articular injection of tocilizumab is better
than that of compound betamethasone.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | March 3, 2018 |
Est. primary completion date | December 12, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Age range: 18-65 years 2. Patients must be diagnosed as rheumatoid arthritis according to the 2010 ACR classification diagnostic criteria for RA for at least 6 months. 3. Patients' knee is swelling or has effusion. 4. Patients have used the same dosage of DMARDs or biologics for at least 6 weeks and continue using the drug until the end of the study. 5. If patients are using glucocorticoid or NSAIDs, the dosage must be stabilized for at least 4 weeks and continue until the end of the study. 6. Patients must understand the aim and steps of this study, can come back for follow-up timely. Exclusion Criteria: 1. Patients' knee is out of shape. X-ray shows a moderate or severe damage of subchondral bone, or joint space is less than 3 mm. 2. Patients have received intra-articular injection of glucocorticoid or TNFi, joint replacement, or synovectomy. 3. Patients is suffering from other autoimmune diseases or Spondyloarthritis. 4. The skin of knee is damaged severely. 5. Patients is suffering from pulmonary tuberculosis, or Chest X-ray shows lesion signs related to tuberculosis. 6. For the last 3 months, patients have participated in other new drug's clinical trial. 7. Other patients who have been thought not suitable for the study by researchers. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change from OMERACT-EULAR composite PDUS synovitis score at 4 weeks | use articular ultrasound to explore the condition of knee and evaluate the condition of knee by OMERACT-EULAR composite PDUS synovitis score | 0 and 4 weeks | |
Secondary | change from disease activity score at 4 weeks | DAS28-CRP, DAS28-ESR | 0 and 4 weeks | |
Secondary | change from Health Assessment Questionnaire at 4 weeks | HAQ | 0 and 4 weeks | |
Secondary | change from Rheumatoid and arthritis outcome score at 4 weeks | RAOS | 0 and 4 weeks | |
Secondary | change from composite change index at 4 weeks | CCI score | 0 and 4 weeks | |
Secondary | change from diameter of knee joint at 4 weeks | diameter of knee joint | 0 and 4 weeks | |
Secondary | change from knee flexion range at 4 weeks | knee flexion range | 0 and 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
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