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A Study of RO5310074 in Patients With Psoriatic Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01199809
First received: September 9, 2010
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

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 who have or have had an inadequate response to oral disease-modifying antirheumatic drugs (DMARDs) or non-steroidal anti-rheumatic drugs (NSAIDs). Patients will be randomized in cohorts to receive either 6 intravenous doses of RO5310074 or placebo. Anticipated time on study treatment is 12 weeks.


Condition Intervention Phase
Arthritis, Psoriatic
 Drug: RO5310074
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Observer-blinded, Multiple-Ascending-Dose, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5310074 Following Multiple Intravenous Administrations in Subjects With Psoriatic Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics (Cmax, t1/2, AUC, Vss, CL) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics (anti-drug-antibodies) [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: February 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO5310074
multiple ascending doses
Placebo Comparator: 2 Drug: Placebo
multiple doses

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199809

Locations
United States, Alabama
Anniston, Alabama, United States, 36207
United States, California
Los Angeles, California, United States, 90036
United States, Florida
Miami, Florida, United States, 33169
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Dallas, Texas, United States, 75231
San Antonio, Texas, United States, 78217
Australia
Melbourne Vic, Australia, 3004
Nedlands, Australia, 6009
New Zealand
Christchurch, New Zealand
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01199809     History of Changes
Other Study ID Numbers: PP22713, 2011-001133-16
Study First Received: September 9, 2010
Last Updated: August 8, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
 Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013