A Study of RO5310074 in Patients With Psoriatic Arthritis

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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Psoriatic
• Intervention / Treatment: Drug: RO5310074; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
• New Zealand
  • Christchurch, New Zealand, 8011
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
  • California
    • Los Angeles, California, United States, 90036
  • Florida
    • Miami, Florida, United States, 33169
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
  • Texas
    • Dallas, Texas, United States, 75231
    • San Antonio, Texas, United States, 78217

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: RO5310074; multiple ascending doses
Placebo Comparator: 2	Drug: Placebo; multiple doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	25 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (Cmax, t1/2, AUC, Vss, CL)	12 weeks
Pharmacodynamics (anti-drug-antibodies)	25 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: PP22713; 2011-001133-16 (EudraCT Number)