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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00761514
Recruitment Status : Terminated (The study was terminated due to low enrollment.)
First Posted : September 29, 2008
Results First Posted : November 19, 2009
Last Update Posted : November 19, 2009
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Humira (adalimumab) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : November 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
All subjects will receive Adalimumab
Drug: Humira (adalimumab)
40 mg eow
Other Names:
  • ABT-D2E7
  • adalimumab
  • Humira

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score [ Time Frame: Week 24 of treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00761514

Puerto Rico
Aguada, Puerto Rico, 00602
Bayamón, Puerto Rico, 00961
AJP Med, Inc. PSA
Caguas, Puerto Rico, 00726
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
Study Director: Carlos R. Rivera-Vàzquez, MD Abbott

Additional Information:
Responsible Party: Carlos R. Rivera-Vázquez, MD/Medical Director, Abbott Identifier: NCT00761514     History of Changes
Other Study ID Numbers: W06-407
First Posted: September 29, 2008    Key Record Dates
Results First Posted: November 19, 2009
Last Update Posted: November 19, 2009
Last Verified: October 2009

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