Clinical trial NCT00761514: Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira
Official title: Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira as Their First Anti-TNF Monoclonal Antibody (VIVIR)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: Week 24 of treatment
Secondary outcomes:
measure: Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score
timeFrame: Week 24 of treatment
Other outcomes:
Locations:
city: Aguada
country: Puerto Rico
city: Bayamón
country: Puerto Rico
city: Caguas
country: Puerto Rico
facility: AJP Med, Inc. PSA
city: Caguas
country: Puerto Rico
city: Humacao
country: Puerto Rico
city: Manati
country: Puerto Rico
city: Rio Piedras
country: Puerto Rico
city: Rio Piedras
country: Puerto Rico
city: San Juan
country: Puerto Rico
facility: San Juan Arthritis & Research Center
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Abbott
name: Carlos R. Rivera-Vàzquez, MD
role: STUDY_DIRECTOR
References: