A Study of RO5310074 in Patients With Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01199809
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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 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 or disease Intervention/treatment Phase
Arthritis, Psoriatic Drug: Placebo Drug: RO5310074 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: RO5310074
multiple ascending doses
Placebo Comparator: 2 Drug: Placebo
multiple doses

Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: 25 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetics (Cmax, t1/2, AUC, Vss, CL) [ Time Frame: 12 weeks ]
  2. Pharmacodynamics (anti-drug-antibodies) [ Time Frame: 25 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01199809

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, Victoria
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
New Zealand
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01199809     History of Changes
Other Study ID Numbers: PP22713
2011-001133-16 ( EudraCT Number )
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases