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NCT Number: NCT01199809

A Study of RO5310074 in Patients 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.

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Key information

Conditions

Arthritis, Psoriatic Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

multiple doses

RO5310074

Drug

multiple ascending doses

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 25 weeks

Secondary outcomes

  1. Pharmacokinetics (Cmax, t1/2, AUC, Vss, CL)

    Time frame: 12 weeks

  2. Pharmacodynamics (anti-drug-antibodies)

    Time frame: 25 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 13, 2010
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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