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Colorado Adult Joint Assessment Scale (CAJAS) Validation (CAJAS)

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ClinicalTrials.gov Identifier: NCT02284789
Recruitment Status : Completed
First Posted : November 6, 2014
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hemophilia A Other: Colorado Adult Joint Assessment Evaluation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : February 2015
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
CAJAS evaluation Other: Colorado Adult Joint Assessment Evaluation
Physical evaluation of 6 joints, ankles, knees and elbows



Primary Outcome Measures :
  1. Colorado Adult Joint Assessment Score (CAJAS) [ Time Frame: Up to 25 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284789


Locations
United States, California
Orange, California, United States, 92868
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Oregon
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02284789     History of Changes
Other Study ID Numbers: 17819
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Bayer:
Hemophilia

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn