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


Phase 2
21 Years
70 Years
Not Enrolling
Both
Rheumatoid Arthritis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

008-MPRA02

NCT ID:

NCT00055133

Start Date:

September 2002

Completion Date:

December 2004

Related Keywords:

  • Rheumatoid Arthritis
  • rheumatoid arthritis
  • Paxceed
  • Micellar Paclitaxel
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Denver Arthritis ClinicDenver, Colorado  80230
Radiant ResearchDaytona Beach, Florida  32114
Ocala Rheumatology Research CenterOcala, Florida  34474
Tampa Medical Group ResearchTampa, Florida  33614
Indiana UniversityIndianapolis, Indiana  46202
Arthritis & Rheumatology Clinic of KansasWichita, Kansas  67214-4976
Arthritis Center of RenoReno, Nevada  89502
Altoona Center for ResearchDuncansville, Pennsylvania  16635-1018