Randomized, Double-Blind, Placebo-Controlled Study to Assess Fatigue in Patients With ACD Due to RA Receiving PROCRIT - Full Text View

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Ortho Biotech Products, L.P.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00236678

Purpose

The purpose of this research study is to determine fatigue (tiredness) in subjects with chronic Rheumatoid Arthritis with chronic anemia. Fatigue in subjects who get PROCRIT will be compared to fatigue in subjects who get placebo (a medically inactive substance). The study will also evaluate hemoglobin levels (oxygen-carrying protein in red blood cells), safety, anemia related health concerns, vitality, arthritis related function and work productivity.

Condition	Intervention	Phase
Anemia Rheumatoid Arthritis	Drug: Epoetin alfa	Phase II

MedlinePlus related topics: Anemia Rheumatoid Arthritis

Drug Information available for: Epoetin alfa Erythropoietin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study to Assess Fatigue in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis Receiving PROCRIT® (Epoetin Alfa)

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

To assess changes in fatigue in patients at least 18 years old with chronic rheumatoid arthritis (RA) and chronic anemia (Hb < 11.0 g/dL) due to ACD receiving weekly s.c. doses of PROCRIT versus placebo.

Secondary Outcome Measures:

Hb response; changes in anemia associated health concerns; changes in vitality; changes in arthritis related function

Estimated Enrollment:	270
Study Start Date:	July 2004
Study Completion Date:	January 2006

Detailed Description:

PROCRIT is not approved for the treatment of anemia of chronic disease in rheumatoid arthritis patients. Approximately 270 subjects will be participating in this trial, at approximately 25 centers in the United States. Patients will be eligible to participate in this study if hemoglobin (Hb) is <=11.0 g/dL. The hypothesis is that PROCRIT improves fatigue scores in rheumatoid arthrits patients with anemia of chronic disease.

If a patient chooses to participate, he/she will be randomized to receive either PROCRIT or placebo on a weekly basis starting at 20,000 units per injection (up to a maximum of 40,000 units).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have rheumatoid arthritis with chronic anemia. Patients must have signed an informed consent
Women must be postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control, or have a negative serum pregnancy test
Women must not be breast feeding during this study period

Exclusion Criteria:

Uncontrolled hypertension
Elective surgery, including joint replacement, anticipated to require transfusion during the extension study period
Thromboembolic event during the double-blind study including acute myocardial infarction, cerebrovascular accident and/or transient ischemic attack
Deep vein thrombosis and/or pulmonary embolism
Uncontrolled psychiatric disease
Planning to be enrolled in any other clinical trial during the course of this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236678

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Ortho Biotech Products, L.P.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

A Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients with Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis Receiving PROCRIT (Epoetin alfa) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Study ID Numbers:	CR004624
Study First Received:	October 7, 2005
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00236678
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Anemia
Rheumatoid arthritis
Hemoglobin level

Study placed in the following topic categories:

Epoetin Alfa
Autoimmune Diseases
Fatigue
Musculoskeletal Diseases
Hematologic Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Anemia
Arthritis, Rheumatoid
Chronic Disease
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases
Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009