Colorado Adult Joint Assessment Scale (CAJAS) Validation

Hemophilia A Clinical Trial

— CAJAS  

Official title:

Content and Psychometric Validation Study of the Colorado Adult Joint Assessment Scale (CAJAS) in Subjects With Moderate to Severe Hemophilia A Treated on Prophylaxis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284789
• Other study ID #: 17819
• Status: Completed
• Phase: N/A
• First received: November 4, 2014
• Last updated: December 2, 2015
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Other:
• Colorado Adult Joint Assessment Evaluation
Physical evaluation of 6 joints, ankles, knees and elbows

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorado Adult Joint Assessment Score (CAJAS)		Up to 25 days	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.