Back to results

A Study of RO5310074 in Patients With Psoriatic Arthritis

Primary Purpose

Arthritis, Psoriatic

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Placebo

RO5310074

About this trial

This is an interventional treatment trial for Arthritis, Psoriatic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Safety: Incidence of adverse events

Secondary Outcome Measures

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

Pharmacodynamics (anti-drug-antibodies)

Full Information

NCT ID

NCT01199809

First Posted

September 9, 2010

Last Updated

October 26, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01199809

Brief Title

A Study of RO5310074 in Patients With Psoriatic Arthritis

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 Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Psoriatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

multiple doses

Intervention Type

Drug

Intervention Name(s)

RO5310074

Intervention Description

multiple ascending doses

Primary Outcome Measure Information:

Title

Safety: Incidence of adverse events

Time Frame

25 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Title

Pharmacodynamics (anti-drug-antibodies)

Time Frame

25 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

12. IPD Sharing Statement

Learn more about this trial

A Study of RO5310074 in Patients With Psoriatic Arthritis

We'll reach out to this number within 24 hrs