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Trial registered on ANZCTR


Registration number
ACTRN12610000694011
Ethics application status
Not yet submitted
Date submitted
17/08/2010
Date registered
20/08/2010
Date last updated
27/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized, blinded study, using multiple increasing doses of RO5310074, studying the effects 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] 252480 0
There is no secondary ID
Universal Trial Number (UTN)
There is no UTN
Trial acronym
PP22713
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic arthritis 257981 0
Condition category
Condition code
Inflammatory and Immune System 258144 258144 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The drug being studied is called RO5310074, and it is administered intravenously (into a vein in the arm).
It is being studied for it's effectiveness in the treatment of psoriatic arthritis.
a) There are 3 dose groups (0.5 mg/Kg, 1.4 mg/Kg and 4.5 mg/Kg).
b) Doses will be administered every 2 weeks.
c) Each group will receive 6 infusions. (There will be a total of 12 weeks where study drug is administered; however, the total study duration is 29 weeks. The rest of the time will consist of the initial screening and post drug out-patient follow up visits).
There will be a minimum of 2 weeks between each infusion to allow for safety and tollerability assessments.
Only 1 dose group will be dosed at a time, once safety and tollerability are assessed and it is deemed safe to continue, the next dose group will be dosed.
d) The total amount of drug (dependant on patient weight) will be diluted in a 500mL bag of 0.9% saline (Sodium Chloride-NaCl) and infused over 1 hour.
Intervention code [1] 257033 0
Treatment: Drugs
Comparator / control treatment
Each patient that enters will have roughly a %28 percent chance of receiving non-active drug (placebo).
The active drug will be administered in the same fashion as the placebo to maintain blinding.
a) The placebo will be normal saline (0.9% Sodium Chloride-NaCl)
b) The placebo will be infused every 2 weeks (6 infusions in total). There will be a total of 12 weeks where placebo is administered; however, the total study duration is 29 weeks. The rest of the time will consist of the initial screening and post placebo out-patient follow up visits.
c) The placebo will be a 500mL bag of 0.9% saline, and administered over 1 hour.
Control group
Placebo

Outcomes
Primary outcome [1] 259009 0
To assess the safety and tollerability of multiple doses of RO5130074 in patients with psoriatic arthirtis.
The safety and tollerability will be assessed at every dosing visit with blood/urine tests, a physical exam (including a disease activity assessment), vital signs taken pre/during/post dosing, Electrocardiogram (ECG), an assessment of 66 joints for swelling and 68 joints for tenderness, and a series of questionnaires to be completed by the patient (patient's assessment of pain and disease activity, and the Health Assessment Questionnaire (HAQ), and one to be completed by the physician (physician's assessment of disease activity).
Timepoint [1] 259009 0
There are 3 dose groups, and within each dose group, there will be 6 infusions given.
Safety and tollerbility will be assessed after every dose (every 2 weeks-there must be a minimum of 2 weeks between doses to assess the safety and tolerability).
This will be measured by vital signs, an ECG, a phisical exam and a urine test done on the day a dose is given (from 0-3 hours pre-dose). Vital signs will be taken 15 minutes pre-dose, 45 minutes into the dose and 1.25hr, 6 hr, 12 hr, 24hr, 48hr, and 72hr post dose. Blood samples will also be taken 3 hr pre-dose, and 1.25hr, 6 hr, 12hr, 24hr, 48hr, and 72 hr post dose.
Secondary outcome [1] 265241 0
To evaluate the pharmacokinetics and pharmacodynamics of multiple doses of RO5130074 (to see where the drug goes within the body and how the body metabolizes it).
Pharmacokinetics and pharmacodynamics will be assessed via blood samples.
Timepoint [1] 265241 0
There are 3 dose groups, and within each dose group, there will be 6 infusions given.
Pharmacokinetics and pharmacodynamics will be assessed via blood samples taken at multiple times through out the study (3 hrs pre dose and 1.25, 6, 12, 24, 48, and 72 hrs post dose).

Eligibility
Key inclusion criteria
1. Male and female subjects, 18 to 75 years of age, inclusive, with psoriatic arthritis diagnosed by the Moll and Wright criteria with peripheral joint involvement of at least 6 months duration; this includes subjects with
psoriatic arthritis subtypes such as arthritis affecting Distal Inter-Phalangeal (DIP) joints, arthritis
mutilans, asymmetric peripheral arthritis, polyarticular arthritis with absence of rheumatoid nodes, and spondylitis with peripheral arthritis
2. Either a high sensitivity C-reactive protein (hsCRP) greater than or equal to 0.7 mg/dL or a
erythrocyte sedimentation rate (ESR) greater than or equal to 20 mm/hr
3. If currently taking Methotrexate (MTX), patients must be willing to receive oral folic acid at a stable dose of at least 5 mg/week
4. A body mass index (BMI) between 18 and 35 kg/m2, inclusive
5. A normal screening ECG
6. Women of child bearing age must be willing to use a reliable method of birth control.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior treatment of any biologic Disease Modifying Anti-Rheumatic Drugs (DMARDS)
2. Topical therapy for treatment of psoriasis within 14 days prior to administration of study drug.
3. Abnormal laboratory tests.
4. Any prior immune diseases.
5. History of any other inflammatory joint disease (other than psoriatic arthritis).
6. History of any skin conditions that would interfere with the evaluation of psoriasis.

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)
Eliglible patients will already have been diagnosed with psoriatic arthritis (PsA). Providing patients meet most of the eligibility criteria, their specialist will approach them regarding the study. Patients will be given information and the informed consent form and will be asked to take this home and discuss it with who ever they choose.
If patients are happy to participate, they will be brought back to see the specialist who will sign the consent form with them, and then the patient can be screened.
The site staff will call an interactive voice response system called IVRS. The patient who will be screened will be entered into the system (date of birth, gender, initials). This IVRS system will randomly assign them (like flipping a coin) to a treatment group and will also assign them a study number. This information will be faxed and/or emailed to the site staff that logged the call. This IVRS system will also allocate the specified drug vials to be administered to the patient.
The site staff will not know the exact dose (or active drug versus placebo) that the patient is being given, they will however know which vials to select for treatment.
The sponsor will have full access to the exact treatment given to each patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once all screening procedures have been completed and results obtained, the information is put into an automated system which will assign the patient a number and will randomly assign them (like flipping a coin) to a treatment or placebo group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2821 0
United Kingdom
State/province [1] 2821 0

Funding & Sponsors
Funding source category [1] 257481 0
Commercial sector/Industry
Name [1] 257481 0
Roche Products Pty Ltd
Country [1] 257481 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Roche Products Pty Ltd
Address
4-10 Inmad Road, Dee Why, NSW
2099
Country
Australia
Secondary sponsor category [1] 256714 0
None
Name [1] 256714 0
Address [1] 256714 0
Country [1] 256714 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259509 0
Alfred Hospital Ethics Commitee
Ethics committee address [1] 259509 0
Ethics committee country [1] 259509 0
Australia
Date submitted for ethics approval [1] 259509 0
23/08/2010
Approval date [1] 259509 0
Ethics approval number [1] 259509 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31534 0
Address 31534 0
Country 31534 0
Phone 31534 0
Fax 31534 0
Email 31534 0
Contact person for public queries
Name 14781 0
Jessica Klaver
Address 14781 0
4-10 Inman Road, Dee Why, NSW
2099
Country 14781 0
Australia
Phone 14781 0
+61 2 9454-9116
Fax 14781 0
+61 2 9454-9686
Email 14781 0
jessica.klaver@roche.com
Contact person for scientific queries
Name 5709 0
Jessica Klaver
Address 5709 0
4-10 Inman Road, Dee Why, NSW
2099
Country 5709 0
Australia
Phone 5709 0
+61 2 9454-9116
Fax 5709 0
+61 2 9454-9686
Email 5709 0
jessica.klaver@roche.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.