Trial Outcomes & Findings for Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira (NCT NCT00761514)

Last Updated: 2009-11-19

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

Week 24 of treatment

Results posted on

2009-11-19

Participant Flow

Subjects were enrolled at 10 study sites in Puerto Rico beginning in November 2006.

Not applicable. This was an open-label study. All enrolled subjects received treatment.

Participant milestones

Participant milestones
Measure	Open-label Treatment With 40 mg Adalimumab Every Other Week All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
Overall Study STARTED	14
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-label Treatment With 40 mg Adalimumab Every Other Week All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	1
Overall Study Health insurance didn't cover study drug	1
Overall Study Problem complying with study visit	1
Overall Study Unable to pay for medications	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label Treatment With 40 mg Adalimumab Every Other Week n=14 Participants All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants
Age Continuous	61.29 years STANDARD_DEVIATION 12.14 • n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Region of Enrollment Puerto Rico	14 participants n=93 Participants

PRIMARY outcome

Timeframe: Week 24 of treatment

Population: Available subject data were used in calculations; 14 at Baseline and 7 at Week 24. Missing data were not imputed.

Outcome measures

Outcome measures
Measure	Open-label Treatment With Adalimumab 40 mg Every Other Week n=14 Participants All subjects received 40 mg adalimumab by subcutaneous injection every other week for up to 24 weeks.
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.	59 Percent change in average total score

SECONDARY outcome

Timeframe: Week 24 of treatment

Population: Available subject data were used in calculations. Missing data were not imputed.

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.

Outcome measures

Outcome measures
Measure	Open-label Treatment With Adalimumab 40 mg Every Other Week n=14 Participants All subjects received 40 mg adalimumab by subcutaneous injection every other week for up to 24 weeks.
Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score	31 Percent change in average score

Adverse Events

Open-label Treatment With 40 mg Adalimumab Every Other Week

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Open-label Treatment With 40 mg Adalimumab Every Other Week n=14 participants at risk All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
Infections and infestations Oropharyngeal herpes simplex pharyngitis	7.1% 1/14
Injury, poisoning and procedural complications Hospitalization due to fall	7.1% 1/14

Other adverse events

Other adverse events
Measure	Open-label Treatment With 40 mg Adalimumab Every Other Week n=14 participants at risk All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
Skin and subcutaneous tissue disorders Erythema surrounding area of Humira injection	7.1% 1/14
Skin and subcutaneous tissue disorders Erythema versicular rash	7.1% 1/14
Skin and subcutaneous tissue disorders Erythema rash	7.1% 1/14
Infections and infestations Fever	7.1% 1/14
Skin and subcutaneous tissue disorders Cellulitis right thigh	7.1% 1/14
Infections and infestations Sore throat	7.1% 1/14
Gastrointestinal disorders Epigastric pain	7.1% 1/14
Skin and subcutaneous tissue disorders Non-pruritic areas of erythema on arms	7.1% 1/14
General disorders Nasal congestion	7.1% 1/14
General disorders Dry mouth	7.1% 1/14
General disorders Hair loss	7.1% 1/14
Eye disorders Dry eyes	7.1% 1/14
Skin and subcutaneous tissue disorders Rash	7.1% 1/14
Skin and subcutaneous tissue disorders Non-painful purplish spots on arms	7.1% 1/14
Cardiac disorders High blood pressure	7.1% 1/14
General disorders Lumbar pain	7.1% 1/14
Cardiac disorders Elevated blood pressure	7.1% 1/14
Gastrointestinal disorders Heartburn	7.1% 1/14
Skin and subcutaneous tissue disorders Rash on arms and whole body	7.1% 1/14

Additional Information

Medical Information Specialist

Abbott

Phone: 1-800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee Investigator shall provide Abbott at least sixty (60) days prior to publication or presentation, with a draft of the same for Abbott's review and comment, to ascertain whether any patentable subject matter or Abbott confidential infromariont are disclosed therin. Abbott shall return comment within sixty (60) days after receipt of the draft.
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Restriction type: OTHER