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

This study has been terminated.
(The study was terminated due to low enrollment.)
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00761514
First received: September 25, 2008
Last updated: October 23, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Humira (adalimumab)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score [ Time Frame: Week 24 of treatment ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: November 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All subjects will receive Adalimumab
Drug: Humira (adalimumab)
40 mg eow
Other Names:
  • ABT-D2E7
  • adalimumab
  • Humira

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761514

Locations
Puerto Rico
Aguada, Puerto Rico, 00602
Bayamón, Puerto Rico, 00961
Caguas, Puerto Rico, 00726
AJP Med, Inc. PSA
Caguas, Puerto Rico, 00726
Humacao, Puerto Rico, 00777
Manati, Puerto Rico, 00674
Rio Piedras, Puerto Rico, 00923
Rio Piedras, Puerto Rico, 00927
San Juan Arthritis & Research Center
San Juan, Puerto Rico, 00910
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Abbott
Investigators
Study Director: Carlos R. Rivera-Vàzquez, MD Abbott
  More Information

Additional Information:
No publications provided

Responsible Party: Carlos R. Rivera-Vázquez, MD/Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00761514     History of Changes
Other Study ID Numbers: W06-407
Study First Received: September 25, 2008
Results First Received: August 26, 2009
Last Updated: October 23, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 19, 2014