- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00055133
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294-7201
- University of Alabama at Birmingham
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Colorado
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Denver, Colorado, United States, 80230
- Denver Arthritis Clinic
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Florida
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Daytona Beach, Florida, United States, 32114
- Radiant Research
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Ocala, Florida, United States, 34474
- Ocala Rheumatology Research Center
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Tampa, Florida, United States, 33614
- Tampa Medical Group Research
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Kansas
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Wichita, Kansas, United States, 67214-4976
- Arthritis & Rheumatology Clinic of Kansas
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Nevada
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Reno, Nevada, United States, 89502
- Arthritis Center of Reno
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635-1018
- Altoona Center for Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- 008-MPRA02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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