Rheumatoid Arthritis Photoimmune Therapy With UVADEX Eligibility NCT00221000 Inclusion Criteria 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). Yes
No
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. Yes
No
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. Yes
No
Patients with a poor tolerability of venipuncture or a lack of adequate venous access for required treatments and blood sampling. Yes
No
Patients who have a known hypersensitivity or allergy to psoralen (methoxsalen) Yes
No
Patients who have a known hypersensitivity or allergy to both heparin and citrate products Yes
No
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 Yes
No
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). Yes
No
Patients whom the Investigator believes cannot be maintained on stable doses of permitted concomitant RA medications throughout the Treatment Period Yes
No
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 Yes
No
Patients who have any known malignant disease (other than basal cell carcinoma) currently or within the last 5 years Yes
No
Patients who have a pre-existing blood dyscrasia such as bone marrow hypoplasia, leukopenia, thrombocytopenia, significant anemia, or a coagulation disorder Yes
No
Patients with a persistent or severe infection within 12 weeks of screening. Yes
No
Patients with a history of drug or alcohol abuse within 12 weeks of screening. Yes
No
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]) Yes
No
Women who are pregnant or lactating Yes
No
Medical Concepts 
