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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Humira (adalimumab) (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Carlos R. Rivera-Vàzquez, MD, Study Director, Affiliation: Abbott


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.

Clinical Details

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 design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- 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


- 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.

Locations and Contacts

Aguada 00602, Puerto Rico

Bayamón 00961, Puerto Rico

Caguas 00726, Puerto Rico

AJP Med, Inc. PSA, Caguas 00726, Puerto Rico

Humacao 00777, Puerto Rico

Manati 00674, Puerto Rico

Rio Piedras 00923, Puerto Rico

Rio Piedras 00927, Puerto Rico

San Juan 00918, Puerto Rico

San Juan Arthritis & Research Center, San Juan 00910, Puerto Rico

Additional Information

Link to product information

Starting date: November 2006
Last updated: October 23, 2009

Page last updated: August 23, 2015

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