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

NCT00761514 | Terminated Phase 4 Results

• 1 other identifier: W06-407
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 10

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

Outcome Measures

Primary Outcomes (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.

  Section 1 of the mHAQ includes subject ratings of difficulty in: dressing; getting out of bed; lifting a full glass to the mouth; walking outdoors on flat ground; bathing; bending to pick up clothes from floor; getting in/out of car, bus, train, plane; walking 2 miles; participating in sports and games; getting a good night's sleep; dealing with feelings of anxiety, being nervous; dealing with feelings of depression, feeling blue. Without any difficulty=0, With some difficulty=1, With much difficulty=2, Unable to do=3. Ratings are summed. The maximum total score is 39. Low total score is good.

  Week 24 of treatment

Secondary Outcomes (1)

• Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score

  Week 24 of treatment

Study Arms (1)

1

EXPERIMENTAL

All subjects will receive Adalimumab

Drug: Humira (adalimumab)

Interventions

Humira (adalimumab) DRUG

40 mg eow

Also known as: ABT-D2E7, adalimumab, Humira

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (10)

Unknown Facility

Aguada, 00602, Puerto Rico

Location

Unknown Facility

Bayamón, 00961, Puerto Rico

Location

AJP Med, Inc. PSA

Caguas, 00726, Puerto Rico

Location

Unknown Facility

Caguas, 00726, Puerto Rico

Location

Unknown Facility

Humacao, 00777, Puerto Rico

Location

Unknown Facility

Manatí, 00674, Puerto Rico

Location

Unknown Facility

Rio Piedras, 00923, Puerto Rico

Location

Unknown Facility

Rio Piedras, 00927, Puerto Rico

Location

San Juan Arthritis & Research Center

San Juan, 00910, Puerto Rico

Location

Unknown Facility

San Juan, 00918, Puerto Rico

Location

Related Links

• Link to product information

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

This study was terminated early due to lack of enrollment. Only 7 subjects completed 24 weeks of treatment. That number is too small to provide reliable data on the effectiveness of the treatment.

Results Point of Contact

• Title: Medical Information Specialist
• Organization: Abbott

1-800-633-9110

Study Officials

• Carlos R. Rivera-Vàzquez, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 29, 2008
• Study Start: November 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 19, 2009
• Results First Posted: November 19, 2009

Record last verified: 2009-10

Locations

PR (10)