NCT01199809

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2011

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

September 9, 2010

Last Update Submit

October 26, 2016

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (1)

  • Safety: Incidence of adverse events

    25 weeks

Secondary Outcomes (2)

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

    12 weeks

  • Pharmacodynamics (anti-drug-antibodies)

    25 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: RO5310074

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

multiple doses

2
RO5310074DRUG

multiple ascending doses

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Anniston, Alabama, 36207, United States

Location

Unknown Facility

Los Angeles, California, 90036, United States

Location

Unknown Facility

Miami, Florida, 33169, United States

Location

Unknown Facility

Duncansville, Pennsylvania, 16635, United States

Location

Unknown Facility

Dallas, Texas, 75231, United States

Location

Unknown Facility

San Antonio, Texas, 78217, United States

Location

Unknown Facility

Melbourne, Victoria, 3004, Australia

Location

Unknown Facility

Nedlands, Western Australia, 6009, Australia

Location

Unknown Facility

Christchurch, 8011, New Zealand

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 13, 2010

Study Start

February 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

NZ(1)US(6)AU(2)