JPRN-UMIN000016928
Recruiting
未知
Targeted Ultrasound in Rheumatoid Arthritis - TURA
eeds University0 sites400 target enrollmentMarch 26, 2015
ConditionsRheumatoid arthritis
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Rheumatoid arthritis
- Sponsor
- eeds University
- Enrollment
- 400
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •General 1\. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 12 months following randomisation. 2\. Any persons that are committed to a psychiatric institution or in prison will be excluded from participation in this study. Study Specific 3\. Patients with a secondary, non\-inflammatory musculoskeletal condition (e.g., osteoarthritis or fibromyalgia) that in the Investigator's opinion is symptomatic 4\. enough to interfere with evaluation of the effect of study drug or the patient's primary diagnosis of RA. 5\. Patients with a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis) or connective tissue diseases, e.g. primary Sjogren's syndrome, systemic sclerosis, systemic lupus erythematosus, polymyositis. 6\. Patients not on a stable dose of methotrexate within 8 weeks of screening, intolerance or contraindications (as per clinician judgment) 7\. Intramuscular, intra\-articular or change in oral corticosteroid within 8 weeks of screening visit. 8\. Oral Prednisolone dose \> 5 mg within 8 weeks of screening 9\. Unable to attend 12\-weekly clinical assessments 10\. Female patients who are breastfeeding, pregnant, or plan to become pregnant during the trial or within twelve weeks following completion of the study. 11\. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol. Excluded Previous or Concomitant Therapy: 12\. Treatment with any investigational agent within 4 weeks (or 5 half\-lives of the investigational drug, whichever is longer) of screening. 13\. Patients who have previously received any biological therapy for RA. 14\. Immunisation with a live/attenuated vaccine within 4 weeks prior to baseline. 15\. Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
Outcomes
Primary Outcomes
Not specified
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