A Study Using Intravenous Paxceed™ to Treat Patients With Rheumatoid Arthritis
A Phase 2 Open-Label Clinical Study Using Intravenous Paxceed™ to Treat Patients With Rheumatoid Arthritis
1 other identifier
interventional
50
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 rheumatoid-arthritis
Started Sep 2002
Typical duration for phase_2 rheumatoid-arthritis
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 19, 2003
CompletedFirst Posted
Study publicly available on registry
February 21, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedJuly 29, 2008
July 1, 2008
February 19, 2003
July 26, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- (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
- +1 more criteria
You may not qualify if:
- (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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-7201, United States
Denver Arthritis Clinic
Denver, Colorado, 80230, United States
Radiant Research
Daytona Beach, Florida, 32114, United States
Ocala Rheumatology Research Center
Ocala, Florida, 34474, United States
Tampa Medical Group Research
Tampa, Florida, 33614, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Arthritis & Rheumatology Clinic of Kansas
Wichita, Kansas, 67214-4976, United States
Arthritis Center of Reno
Reno, Nevada, 89502, United States
Altoona Center for Research
Duncansville, Pennsylvania, 16635-1018, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 19, 2003
First Posted
February 21, 2003
Study Start
September 1, 2002
Study Completion
December 1, 2004
Last Updated
July 29, 2008
Record last verified: 2008-07