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Trial record 8 of 272 for:    Betamethasone

The Comparative Study of Intra-articular Injection of Tocilizumab and Compound Betamethasone

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ClinicalTrials.gov Identifier: NCT03215407
Recruitment Status : Unknown
Verified July 2017 by Jian Zhu, Chinese PLA General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 12, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Jian Zhu, Chinese PLA General Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis of Knee Drug: Intra-articular Tocilizumab Drug: Intra-articular Compound Betamethasone Phase 4

Detailed Description:

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, the study period is 4 weeks.

Sample size: 60 cases. Study content: Patients who meet inclusive criteria will be randomly divided into tocilizumab group and compound betamethasone group according to the random number table. 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.

Index of effect evaluation: 1) Articular ultrasound, OMERACT-EULAR composite PDUS synovitis score will be used to evaluate the condition of articulation; 2) Disease activity score, DAS28-CRP, DAS28-ESR; 3) Health Assessment Questionnaire, HAQ; 4) Rheumatoid and arthritis outcome score, RAOS; 5) composite change index, CCI score; 6) diameter of knee joint; 7) knee flexion range.

Hypothesis: The efficacy and safety of intra-articular injection of tocilizumab is better than that of compound betamethasone.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 12, 2017
Estimated Study Completion Date : March 3, 2018


Arm Intervention/treatment
Experimental: Intra-articular Tocilizumab
Tocilizumab, solution, 80mg intra-articular.
Drug: Intra-articular Tocilizumab
Patients will be randomly chosen to be intra-articular injected of tocilizumab injection

Active Comparator: Intra-articular Compound Betamethasone
Compound betamethasone, solution, 14mg intra-articular
Drug: Intra-articular Compound Betamethasone
Patients will be randomly chosen to be intra-articular injected of compound betamethasone injection




Primary Outcome Measures :
  1. change from OMERACT-EULAR composite PDUS synovitis score at 4 weeks [ Time Frame: 0 and 4 weeks ]
    use articular ultrasound to explore the condition of knee and evaluate the condition of knee by OMERACT-EULAR composite PDUS synovitis score


Secondary Outcome Measures :
  1. change from disease activity score at 4 weeks [ Time Frame: 0 and 4 weeks ]
    DAS28-CRP, DAS28-ESR

  2. change from Health Assessment Questionnaire at 4 weeks [ Time Frame: 0 and 4 weeks ]
    HAQ

  3. change from Rheumatoid and arthritis outcome score at 4 weeks [ Time Frame: 0 and 4 weeks ]
    RAOS

  4. change from composite change index at 4 weeks [ Time Frame: 0 and 4 weeks ]
    CCI score

  5. change from diameter of knee joint at 4 weeks [ Time Frame: 0 and 4 weeks ]
    diameter of knee joint

  6. change from knee flexion range at 4 weeks [ Time Frame: 0 and 4 weeks ]
    knee flexion range



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Jian Zhu, Associated Prof. of Medicine, Deputy Director of Rheumatology, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03215407     History of Changes
Other Study ID Numbers: ChinaPLAGH(Intraarticular+TCZ)
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents