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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00055133
Recruitment Status : Completed
First Posted : February 21, 2003
Last Update Posted : July 29, 2008
Information provided by:
Angiotech Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Micellar Paclitaxel for Injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-Label Clinical Study Using Intravenous Paxceed™ to Treat Patients With Rheumatoid Arthritis
Study Start Date : September 2002
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00055133

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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

Layout table for additonal information Identifier: NCT00055133     History of Changes
Other Study ID Numbers: 008-MPRA02
First Posted: February 21, 2003    Key Record Dates
Last Update Posted: July 29, 2008
Last Verified: July 2008
Keywords provided by Angiotech Pharmaceuticals:
rheumatoid arthritis
Micellar Paclitaxel
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action