Description:

Eligibility NCT00221000 Rheumatoid Arthritis Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis (RA-1) ODM derived from http://clinicaltrials.gov/show/NCT00221000

Link:

http://clinicaltrials.gov/show/NCT00221000

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Versions (3) ▾
  1. 2/10/12
  2. 4/13/14
  3. 6/6/15
Uploaded on:

June 6, 2015

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Creative Commons BY 4.0
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Rheumatoid Arthritis Photoimmune Therapy With UVADEX Eligibility NCT00221000

Details

Eligibility Rheumatoid Arthritis NCT00221000

Inclusion Criteria
18 Years and older
Patients must have a history of RA per the ACR criteria for the classification of RA
Patients must have moderately to severely active RA
Patients who are not on oral corticosteroids OR Patients who have been on a stable dose of oral corticosteroids at a prednisone equivalent dosage greater than or equal to 15 mg/day for at least 4 weeks prior to screening.
Patients must have a platelet count greater than or equal to 100,000/cmm.
Female patients must be one of the following: postmenopausal, surgically incapable of bearing children, practicing an acceptable method of birth control (acceptable methods may include hormonal contraceptives, intrauterine device, and spermicide and barrier). Abstinence or partner/spouse sterility may also qualify at the Investigator's discretion. If a female patient is of childbearing potential, she must have a negative urine pregnancy test at screening.
Patients must be able and willing to comply with all study procedures
Patients must be willing to sign an ICF
Patients must have a body weight greater than or equal to 40 kg (88 lb).
Exclusion Criteria
Patients who have a form of arthritis or arthropathy, other than RA, or any current inflammatory condition that might confound the assessments (e.g., other connective tissue diseases or Lyme disease).
Patients who have been enrolled in any investigational therapy study for the treatment of RA within 4 weeks prior to the start of the Treatment Period, or patients who are scheduled to receive investigational therapies or a plasma based apheresis procedure (e.g., a protein A column) for the treatment of RA during the course of the study.
Patients unable to tolerate the extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe chronic obstructive pulmonary disease, severe asthma, renal failure, or hepatic failure.
Patients with a poor tolerability of venipuncture or a lack of adequate venous access for required treatments and blood sampling.
Patients who have a known hypersensitivity or allergy to psoralen (methoxsalen)
Patients who have a known hypersensitivity or allergy to both heparin and citrate products
Patients who are taking any of the following permitted DMARDs and biological agents and have not been on a stable dose for the specific indicated periods of time prior to screening: MTX for at least 8 weeks; leflunomide for at least 8 weeks; infliximab for at least 14 weeks; etanercept for at least 12 weeks; adalimumab for at least 12 weeks
Patients who are taking any of the following permitted medications and have not been on a stable dose for at least 4 weeks prior to screening: NSAIDs; anakinra; hydroxychloroquine; chloroquine; sulfasalazine; D-penicillamine; gold salts; azathioprine; oral corticosteroids (greater than or equal to 15 mg/day, prednisone equivalent dose).
Patients whom the Investigator believes cannot be maintained on stable doses of permitted concomitant RA medications throughout the Treatment Period
Patients who are taking any of the following prohibited medications: cyclophosphamide; chlorambucil; intramuscular (IM) or intravenous (IV) corticosteroid injection(s), within 4 weeks of screening; intra-articular corticosteroid injection(s) > 60 mg prednisone equivalent total dose, within 4 weeks of screening
Patients who have any known malignant disease (other than basal cell carcinoma) currently or within the last 5 years
Patients who have a pre-existing blood dyscrasia such as bone marrow hypoplasia, leukopenia, thrombocytopenia, significant anemia, or a coagulation disorder
Patients with a persistent or severe infection within 12 weeks of screening.
Patients with a history of drug or alcohol abuse within 12 weeks of screening.
Patients with impaired hepatic function at screening as shown by abnormal liver function tests (LFT; i.e., aspartate transaminase [AST] or alanine transaminase [ALT] levels > 2 x the upper limit of normal [ULN])
Women who are pregnant or lactating
Medical Concepts
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