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Mechanism of action study of anti-IL17 treatment in spondyloarthritis.

Conditions
Spondyloarthritis
MedDRA version: 16.1Level: LLTClassification code 10032155Term: Other inflammatory spondylopathiesSystem Organ Class: 100000004859
MedDRA version: 16.1Level: LLTClassification code 10070759Term: SpondylopathySystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Registration Number
EUCTR2013-002709-79-NL
Lead Sponsor
Academic Medical Center, Department of Rheumatology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

-Male or non-pregnant/non-lactating females age 18-70
- Diagnosis of SpA according to ESSG criteria and/or ASAS criteria
- Active disease defined by =1 swollend and = 1 tender joint, and at least 1 swollen knee or ankle joint at baseline
- stable dose of concomitant medication (NSAIDs etc.)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Evidence for infectious or malignant process (on chest X ray/MRI etc)
- Pts taking opioid angalgetics
- Previous IL-17 therapy exposure
- Previous use of celldepleting therapies, biological immunomodulants (except for a.TNF)
- Significant medical problems or diseases

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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