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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01199809




Registration number
NCT01199809
Ethics application status
Date submitted
9/09/2010
Date registered
13/09/2010
Date last updated
27/10/2016

Titles & IDs
Public title
A Study of RO5310074 in Patients With Psoriatic Arthritis
Scientific 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
Secondary ID [1] 0 0
2011-001133-16
Secondary ID [2] 0 0
PP22713
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - RO5310074

Experimental: 1 -

Placebo Comparator: 2 -


Treatment: Drugs: Placebo
multiple doses

Treatment: Drugs: RO5310074
multiple ascending doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: Incidence of adverse events
Timepoint [1] 0 0
25 weeks
Secondary outcome [1] 0 0
Pharmacokinetics (Cmax, t1/2, AUC, Vss, CL)
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Pharmacodynamics (anti-drug-antibodies)
Timepoint [2] 0 0
25 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
- Melbourne
Recruitment hospital [2] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
New Zealand
State/province [6] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01199809
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01199809