Rheumatoid Arthritis
Conditions
Brief summary
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.
Interventions
40 mg eow
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures. * Subject is 18 years of age or older. * If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: * condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD). * contraceptives (oral or parenteral) for three months prior to study drug administration). * a vasectomized partner. * total abstinence from sexual intercourse. * If female, the results of a serum pregnancy test performed at Screening, prior to the first dose of Humira (adalimumab) must be negative. * Subject has confirmed diagnosis of active rheumatoid arthritis as defined by \>= 6 swollen joints and \>= 9 tender joints. * Subject has an Erythrocyte Sedimentation Rate (ESR) of \> 20 mm/hr. ESR will be measured using the Westergren method. * Subject meets the American College of Rheumatology (ACR) criteria for diagnosis of rheumatoid arthritis (RA) for at least 3 months prior to enrollment and requires to be started in a biologic containing treatment for the first time, and the investigator chooses Humira (adalimumab). * Subject has had unsatisfactory response or intolerance to one or more prior disease-modifying antirheumatic drugs (DMARDS) (e.g., hydroxychloroquine, leflunomide, methotrexate, parenteral gold, sulfasalazine, azathioprine or any combination of those). * Subject will have an evaluation for latent tuberculosis with a tuberculosis (TB) skin test done in the screening visit. Subjects who have evidence of prior TB infection should be given prophylaxis in accordance with Centers for Disease Control and Prevention (CDC) guidelines.
Exclusion criteria
* Subjects who have had prior treatment with cyclophosphamide, chlorambucil or any other Tumor Necrosis Factor (TNF) biologic as etanercept, infliximab, anakinra, abatacept and adalimumab. * Subjects who have been previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in persistent CD4 lymphopenia (CD4 lymphocytes \<= 500/mm3). * Subject has had prior treatment with intravenous (IV) immunoglobulin or any investigational agent within 30 days of screening visit. * Subject has a history of cancer within the past 10 years other than resected basal cell or squamous cell carcinomas of the skin. * Subject has a history of malignant lymphoma or leukemia regardless of time since diagnosis. * Subject has a history of or current acute inflammatory joint disease of origin other than RA, e.g., Mixed Connective Tissue Disease (MCTD), Systematic Lupus Erythematosus (SLE), etc. * Subject has a history of uncontrolled diabetes mellitis, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent cerebrovascular accident (CVA) (within 3 months) which, in the opinion of the investigator, would put the subject at risk by participation in the protocol. * Subject has a history of active tuberculosis or listeriosis, or other active infections suggestive of significant or profound immunosuppression, such as Pneumocystis carinii, aspergillosis or other systemic protozoan or fungal infections. * Subject has a positive serology for Hepatitis B or Hepatitis C indicating active infection. * Subject has a history of positive HIV status defined by an enzyme-linked immunosorbent assay (ELISA) positive test confirmed by a Western blot test and/or polymerase chain reaction (PCR). * Subject has had a persistent or severe infection(s) requiring hospitalization or treatment with intravenous (IV) antibiotics within 30 days, or oral antibiotics within 14 days, prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Week 24 of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score | Week 24 of treatment | 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. |
Countries
Puerto Rico
Participant flow
Recruitment details
Subjects were enrolled at 10 study sites in Puerto Rico beginning in November 2006.
Pre-assignment details
Not applicable. This was an open-label study. All enrolled subjects received treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Health insurance didn't cover study drug | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Problem complying with study visit | 1 |
| Overall Study | Unable to pay for medications | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Open-label Treatment With 40 mg Adalimumab Every Other Week |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age Continuous | 61.29 years STANDARD_DEVIATION 12.14 |
| Region of Enrollment Puerto Rico | 14 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 14 |
| serious Total, serious adverse events | 2 / 14 |
Outcome results
Primary
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
Population: Available subject data were used in calculations; 14 at Baseline and 7 at Week 24. Missing data were not imputed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open-label Treatment With Adalimumab 40 mg Every Other Week | 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
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
Population: Available subject data were used in calculations. Missing data were not imputed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open-label Treatment With Adalimumab 40 mg Every Other Week | Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score | 31 Percent change in average score |