A Study Using Intravenous Paxceed™ to Treat Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00055133
First received: February 19, 2003
Last updated: July 26, 2008
Last verified: July 2008
  Purpose

Paxceed™ is being developed by Angiotech Pharmaceuticals, Inc. for the treatment of Rheumatoid Arthritis (RA). The main objective of this study is to determine the effectiveness of treatment with Paxceed™ in patients with RA. In RA, there is an increase in cell growth and changes in cell function. The active substance in Paxceed™, paclitaxel, has undergone clinical studies as a cancer chemotherapeutic agent and has demonstrated its usefulness as an agent that stops growth of cells and blocks certain types of cell function associated with RA. Because of these effects, it is thought that Paxceed™ might alter the destructive course of RA.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Micellar Paclitaxel for Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open-Label Clinical Study Using Intravenous Paxceed™ to Treat Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Angiotech Pharmaceuticals:

Estimated Enrollment: 50
Study Start Date: September 2002
Estimated Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(i) Signed informed consent in accordance with applicable regulations

(ii) Males and females aged 21 to 70 years inclusive

(iii) Must have failed at least one DMARD

(iv) Rheumatoid Arthritis fulfilling 1987 ACR revised criteria

(v) Active RA as defined by:

  • ≥6 swollen and ≥9 tender joints
  • CRP ≥0.8 mg/dL or morning stiffness ≥45 minutes

(vi) If female and of child bearing potential, she must:

  • have a negative serum pregnancy test, and
  • be using two forms of an effective method of contraception (one form being a barrier method) or be surgically incapable of bearing children or abstinent.

If male and heterosexual, he must:

  • agree to use condoms with spermicide throughout the study and for at least 12 weeks following the last infusion.
  • vasectomy is an acceptable form of contraception for males and partners of females

(vii) Adequate venous access as defined by the Principal Investigator

(viii) If taking non-steroidal anti-inflammatory medications, must be on stable regimen for four weeks prior to the Screening visit

(ix) If taking prednisone (≤ 10 mg) or equivalent, must be on stable regimen for four weeks prior to Screening visit

Exclusion Criteria:

(i) Prior or current treatment with alkylating agents, or radiation

(ii) Treatment with colchicine within six months prior to Screening

(iii) Experimental anti-rheumatic drugs within 90 days (or five half-lives, whichever is longer) prior to screening

(iv) DMARD therapy four weeks prior to Baseline visit

(v) Intra-articular corticosteroids four weeks prior to the Screening visit

(vi) Bedridden or wheelchair bound patients

(vii) Pregnant or lactating females

(viii) Interstitial lung disease

(ix) Clinically significant cardiac risk factors, including a history of congestive heart failure, angina, and myocardial infarction within the previous six months

(x) History of malignancy, except (a) basal cell carcinoma of the skin and in situ cervical carcinoma that have been excised with no recurrence or treatment within the last five years, and (b) low-grade prostate cancer

(xi) Major organ allograft, or uncontrolled cardiac, hepatic, pulmonary, renal or central nervous system disease, know clotting deficiency, or any illness that increases undue risk to patient

(xii) History of anaphylactic reactions

(xiii) WBC count <4,000/mm3; Neutrophils <2,000/mm3; Platelet count <125,000/mm3; hemoglobin <9g/dL; creatinine >1.4 times the upper limit of normal; liver function test >1.2 times the upper limit of normal

(xiv) Presence of Hepatitis B Surface antigen (HbsAg), Hepatitis C antibody (HCVAb), and/or Hepatitis C quantitative assay, or history of hepatitis (such as autoimmune hepatitis) within one year prior to Screening

(xv) Presence of any confounding illness or syndromes that may interfere with proper evaluation of efficacy, such as other autoimmune disease, psoriatic arthritis, lupus or scleroderma

(xvi) Patients determined by the investigator (e.g., because of known or probable alcohol or drug abuse) to be unreliable for follow-up

  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: NCT00055133

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-7201
United States, Colorado
Denver Arthritis Clinic
Denver, Colorado, United States, 80230
United States, Florida
Radiant Research
Daytona Beach, Florida, United States, 32114
Ocala Rheumatology Research Center
Ocala, Florida, United States, 34474
Tampa Medical Group Research
Tampa, Florida, United States, 33614
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
Arthritis & Rheumatology Clinic of Kansas
Wichita, Kansas, United States, 67214-4976
United States, Nevada
Arthritis Center of Reno
Reno, Nevada, United States, 89502
United States, Pennsylvania
Altoona Center for Research
Duncansville, Pennsylvania, United States, 16635-1018
Sponsors and Collaborators
Angiotech Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00055133     History of Changes
Other Study ID Numbers: 008-MPRA02
Study First Received: February 19, 2003
Last Updated: July 26, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Angiotech Pharmaceuticals:
rheumatoid arthritis
Paxceed
Micellar Paclitaxel

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014