Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With ACD Due to RA Receiving PROCRIT

This study has been terminated.
(This study was terminated due to slow enrollment, despite protocol amendments to change the entrance criteria.)
Sponsor:
Collaborator:
Ortho Biotech Products, L.P.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236678
First received: October 7, 2005
Last updated: June 8, 2011
Last verified: March 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:


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

Enrollment: 29
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 arthritis 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00236678     History of Changes
Other Study ID Numbers: CR004624
Study First Received: October 7, 2005
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anemia
Rheumatoid arthritis
Hemoglobin level

Additional relevant MeSH terms:
Anemia
Arthritis
Arthritis, Rheumatoid
Hematologic Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014