Colorado Adult Joint Assessment Scale (CAJAS) Validation

Not Applicable

Completed

• Conditions: Hemophilia A
• Interventions: Other: Colorado Adult Joint Assessment Evaluation

• Registration Number: NCT02284789
• Lead Sponsor: Bayer

Brief Summary

To obtain evidence of content validity and reliability of the Colorado Adult Joint Assessment Scale (CAJAS), a clinician-reported outcome (ClinRO) measure, as adapted for use in a population of adults with moderate to severe hemophilia A treated with coagulation factor VIII (FVIII) therapy as secondary prophylaxis or episodic treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-06
• Study Start: 2015-02
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Male, 18 to 50 years of age
• Diagnosis of moderate to severe hemophilia A (documented <1-2% Factor VIII Concentration [FVIII:C])
• Willing to maintain current FVIII treatment regimen, whether prophylactic or on-demand, for the duration of the study

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Exclusion Criteria

• Routine need for wheelchair or routine need for two canes or crutches
• Diagnosis of another bleeding disorder such as von Willebrand Disease
• Known event that would interfere with the scheduled CAJAS evaluations (e.g., elective joint surgery, vacation)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAJAS evaluation	Colorado Adult Joint Assessment Evaluation	-

Primary Outcome Measures

Name	Time	Method
Colorado Adult Joint Assessment Score (CAJAS)	Up to 25 days