Status:
COMPLETED
A Study of RO5310074 in Patients With Psoriatic Arthritis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Arthritis, Psoriatic
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This randomized, double-blind. placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of RO5310074 in patients with psoriatic arthritis ...
Eligibility Criteria
Inclusion
- Adult patients, 18 - 75 years of age
- Diagnosis of Psoriatic Arthritis (Moll and Wright or CASPAR criteria) of \>/= 6 months duration
- Have \>/= 3 swollen and \>/= 3 tender joints
- Inadequate response to a current or previous oral DMARD or NSAID therapy
- Current oral DMARDs must be at stable dose for the appropriate duration (e.g. 14 days for sulfasalazine and 28 days for methotrexate or oral steroids)
- NSAIDs up to maximum recommended dose are permitted if at stable dose for at least 14 days prior to first dose of study drug, but not more than one NSAID simultaneously (except for low-dose aspirin for cardioprotection)
- Body mass index (BMI) 18 - 42 kg/m2 inclusive
Exclusion
- Previous prolonged treatment with a biologic DMARD; use of biologic DMARD within 3 months or 5 times its elimination half-live (whichever is longer) prior to first dose of study drug
- Previous use of B-cell depleting biologic DMARDs
- Any previous treatment with alkylating agents such a cyclophosphamide or chlorambucil or with total lymphoid irradiation
- History of or current inflammatory joint disease other than psoriatic arthritis; Gout or pseudogout that is current or has been active within the past 6 months
- Positive for hepatitis B, hepatitis C or HIV infection
- Any acquired or congenital immune deficiency or history of disease known to cause significant alteration in immunologic function
- Acute clinically significant infection in the 6 weeks prior to administration of study drug, history or presence of chronic infection, or history of recurrent infection as an adult
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01199809
Start Date
February 1 2011
End Date
February 1 2012
Last Update
October 27 2016
Active Locations (9)
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1
Anniston, Alabama, United States, 36207
2
Los Angeles, California, United States, 90036
3
Miami, Florida, United States, 33169
4
Duncansville, Pennsylvania, United States, 16635