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

NCT ID: NCT00761514

Last Updated: 2009-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-08-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

All subjects will receive Adalimumab

Group Type: EXPERIMENTAL

Humira (adalimumab)

Intervention Type: DRUG

40 mg eow

Interventions

Humira (adalimumab)

40 mg eow

Intervention Type: DRUG

Other Intervention Names

ABT-D2E7; adalimumab; Humira

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott

Principal Investigators

Carlos R. Rivera-Vàzquez, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Aguada, , Puerto Rico

Bayamón, , Puerto Rico

AJP Med, Inc. PSA

Caguas, , Puerto Rico

Caguas, , Puerto Rico

Humacao, , Puerto Rico

Manatí, , Puerto Rico

Rio Piedras, , Puerto Rico

Rio Piedras, , Puerto Rico

San Juan Arthritis & Research Center

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Countries

Puerto Rico

Related Links

http://www.humira.com/

Link to product information

Other Identifiers

W06-407

Identifier Type: -

Identifier Source: org_study_id