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A Study of RO5310074 in Patients With Psoriatic Arthritis

NCT ID: NCT01199809

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Arthritis, Psoriatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

RO5310074

Intervention Type DRUG

multiple ascending doses

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

multiple doses

Interventions

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Placebo

multiple doses

Intervention Type DRUG

RO5310074

multiple ascending doses

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Anniston, Alabama, United States

Site Status

Los Angeles, California, United States

Site Status

Miami, Florida, United States

Site Status

Duncansville, Pennsylvania, United States

Site Status

Dallas, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Melbourne, Victoria, Australia

Site Status

Nedlands, Western Australia, Australia

Site Status

Christchurch, , New Zealand

Site Status

Countries

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Hungary United States Australia New Zealand

Other Identifiers

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2011-001133-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PP22713

Identifier Type: -

Identifier Source: org_study_id