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Rheumatoid ArthritisPhase 2NCT00055133

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

A Phase 2 study testing Micellar Paclitaxel for Injection in people with Rheumatoid Arthritis, run by Angiotech Pharmaceuticals at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Micellar Paclitaxel for Injection
Type of treatment
Injection or infusion
How many people
50 participants
Where
9 sitesUnited States
Study dates
Sep 2002to Dec 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent in accordance with applicable regulations
  • Males and females aged 21 to 70 years inclusive
  • Must have failed at least one DMARD
  • Rheumatoid Arthritis fulfilling 1987 ACR revised criteria
  • Active RA as defined by:
  • ≥6 swollen and ≥9 tender joints
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  • CRP ≥0.8 mg/dL or morning stiffness ≥45 minutes
  • 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
  • Adequate venous access as defined by the Principal Investigator
  • If taking non-steroidal anti-inflammatory medications, must be on stable regimen for four weeks prior to the Screening visit
  • If taking prednisone (≤ 10 mg) or equivalent, must be on stable regimen for four weeks prior to Screening visit

Who cannot join

  • Prior or current treatment with alkylating agents, or radiation
  • Treatment with colchicine within six months prior to Screening
  • Experimental anti-rheumatic drugs within 90 days (or five half-lives, whichever is longer) prior to screening
  • DMARD therapy four weeks prior to Baseline visit
  • Intra-articular corticosteroids four weeks prior to the Screening visit
  • Bedridden or wheelchair bound patients
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  • Pregnant or lactating females
  • Interstitial lung disease
  • Clinically significant cardiac risk factors, including a history of congestive heart failure, angina, and myocardial infarction within the previous six months
  • 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
  • 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
  • History of anaphylactic reactions
  • 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
  • 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
  • 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
  • Patients determined by the investigator (e.g., because of known or probable alcohol or drug abuse) to be unreliable for follow-up

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-7201

  • Radiant Research

    Daytona Beach, Florida, 32114

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

  • Altoona Center for Research

    Duncansville, Pennsylvania, 16635-1018

  • Indiana University

    Indianapolis, Indiana, 46202

  • Ocala Rheumatology Research Center

    Ocala, Florida, 34474

  • Arthritis Center of Reno

    Reno, Nevada, 89502

  • Tampa Medical Group Research

    Tampa, Florida, 33614

  • Arthritis & Rheumatology Clinic of Kansas

    Wichita, Kansas, 67214-4976

Other trials in United States

About this study

Official title: A Phase 2 Open-Label Clinical Study Using Intravenous Paxceed™ to Treat Patients With Rheumatoid Arthritis

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.

Being tested
Micellar Paclitaxel for Injection
Keywords
rheumatoid arthritis, Paxceed, Micellar Paclitaxel
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Micellar Paclitaxel for InjectionDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2003 (estimated)
  2. Study startSep 2002
  3. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00055133
Sponsor's protocol ID
008-MPRA02
Status last verified
Jul 2008
First submitted
19 Feb 2003
Last updated
29 Jul 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Micellar Paclitaxel for Injection in people with Rheumatoid Arthritis, run by Angiotech Pharmaceuticals at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00055133.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2008.

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