Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira

Sponsor
Abbott
Study ID
NCT00761514
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The primary objective of this study is to evaluate quality of life changes in Puerto Rican subjects with Rheumatoid Arthritis treated with Humira (adalimumab) as their first Anti-TNF Monoclonal Antibody.

Key Dates

Start date
Nov 30, 2006
Status verified
Oct 2009
Primary completion
Aug 31, 2008
Completion
Aug 31, 2008

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    All subjects will receive Adalimumab

Primary Outcome Measure

Percent Change From Baseline to Week 24 in Average Score on Section 1 of the Modified Multi-Dimensional Health Assessment Questionnaire (mHAQ) That Includes Ratings of Sleep, Anxiety, Depression or Feeling Blue, and Ability to do Daily Activities. [ Time Frame: Week 24 of treatment ]

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