A Study of RO5310074 in Patients With Psoriatic Arthritis

Arthritis, Psoriatic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199809
• Other study ID #: PP22713
• Secondary ID: 2011-001133-16
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2010
• Last updated: October 26, 2016
• Start date: February 2011
• Est. completion date: February 2012

Study information

• Verified date: October 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Drug:
• Placebo
multiple doses
• RO5310074
multiple ascending doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		25 weeks	No
Secondary	Pharmacokinetics (Cmax, t1/2, AUC, Vss, CL)		12 weeks	No
Secondary	Pharmacodynamics (anti-drug-antibodies)		25 weeks	No