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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
40 mg eow
Unnamed facility
Aguada, Puerto Rico
Unnamed facility
Bayamón, Puerto Rico
AJP Med, Inc. PSA
Caguas, Puerto Rico
Unnamed facility
Caguas, Puerto Rico
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.
Section 1 of the mHAQ includes subject ratings of difficulty in: dressing; getting out of bed; lifting a full glass to the mouth; walking outdoors on flat ground; bathing; bending to pick up clothes from floor; getting in/out of car, bus, train, plane; walking 2 miles; participating in sports and games; getting a good night's sleep; dealing with feelings of anxiety, being nervous; dealing with feelings of depression, feeling blue. Without any difficulty=0, With some difficulty=1, With much difficulty=2, Unable to do=3. Ratings are summed. The maximum total score is 39. Low total score is good.
Time frame: Week 24 of treatment
Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score
On visual analog scale (VAS), patient marks activity of rheumatoid arthritis in previous 24 hours (0 mm=no symptoms; 100 mm=very active). On another VAS, patient marks how much pain (0 mm=no pain; 100 mm=severe pain) he/she had because of the illness in previous week. Patient also marks tender joints and swollen joints on body diagrams. Number of swollen and painful joints and values on VAS are used with erythrocyte sedimentation rate to calculate the patient's global assessment of disease activity. High score indicates high activity.
Time frame: Week 24 of treatment
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Unnamed facility
Humacao, Puerto Rico
Unnamed facility
Manati, Puerto Rico
Unnamed facility
Rio Piedras, Puerto Rico
Unnamed facility
Rio Piedras, Puerto Rico
San Juan Arthritis & Research Center
San Juan, Puerto Rico
Unnamed facility
San Juan, Puerto Rico