|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
25 May 2015 |
|
Main ID: |
NCT01395251 |
|
Date of registration:
|
12/07/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis
TryCort |
|
Scientific title:
|
Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis |
|
Date of first enrolment:
|
February 2012 |
|
Target sample size:
|
130 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01395251 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
|
|
Phase:
|
Phase 2/Phase 3
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Juergen Braun, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Rheumazentrum Ruhrgebiet, Herne, Germany |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- pain in wrist and fingers without known diagnosis since more than 6 weeks, minimum of
pain on a numerical rating scale 4 (out of 10)
Exclusion Criteria:
- rheumatoid arthritis
- psoriatic arthritis
- psoriasis vulgaris
- vasculitis
- gouty arthritis
- Current glucocorticoidmedication
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Rheumatoid Arthritis
|
|
Intervention(s)
|
|
Drug: Prednisolone
|
|
Primary Outcome(s)
|
|
Rate of true diagnosis of rheumatoid arthritis after positive prednisolone test
[Time Frame: 3 months]
|
|
Positive predictive value
[Time Frame: 3 months]
|
|
Rate of true negative diagnosis of rheumatoid arthritis after positive prednisolone test
[Time Frame: 3 months]
|
|
Negative predictive value
[Time Frame: 3 months]
|
|
Secondary Outcome(s)
|
|
clinical characteristics of patients with early RA
[Time Frame: 3 months]
|
|
change of disease activity
[Time Frame: 3 months]
|
|
change of functioning
[Time Frame: 3 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|