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Ustekinumab

Phase 2

Ankylosing Spondylitis | Small molecule | Immunology |Pulmonx Corporation|Last Updated: Jun 4, 2013

Success Probability

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

Ustekinumab · 1 trial · 1 indication

Phase 2 1
NCT01330901Ustekinumab for the Treatment of Patients With Active Ankylosing SpondylitisAnkylosing Spondylitis
COMPLETED22 Analytics
PHASE2COMPLETED
Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis
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Study Endpoints

Primary Endpoints

The Assessment of Spondyloarthritis International Society (ASAS)40 response
week 24

The percentage of patients who achieved ASAS40 response defined as an improvement of ≥40% and ≥2 points in at least 3 out of four following domains (and no worsening in remaining domain): * Patient global * Pain * Function (as measured by the Bath Ankylosing Spondylitis Functional Index - BASFI) * Inflammation (mean of the Bath Ankylosing Spondylitis Disease Activity Index - BASDAI question 5 and 6)

Secondary Endpoints

The Assessment of Spondyloarthritis International Society (ASAS)20 response at week 24
Week 24
The Ankylosing Spondylitis Disease Activity Score (ASDAS) clinically important improvement
Week 24
The Assessment of Spondyloarthritis International Society (ASAS) partial remission
Week 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
UstekinumabEXPERIMENTALUstekinumab 90 mg subcutaneously at week 0, 4 and 16

Interventions

NameTypeDescription
UstekinumabDRUGUstekinumab 90 mg given subcutaneously at weeks 0, 4, and 16
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age of ≥18 years. 2. Definite diagnosis of AS according to the modified New York criteria. 3. History of an inadequate response to ≥2 NSAIDs taken for at least 2 weeks each or NSAIDs intolerance/contraindication. 4. Active disease as defined by a BASDAI value of ≥4 at screeni...

Countries:Germany
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