Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000555358
Ethics application status
Approved
Date submitted
17/10/2008
Date registered
6/11/2008
Date last updated
11/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study looking at the safety, tolerability absorption, breakdown, and elimination of SCH 900117 from the body in Healthy Volunteers and patients with Rheumatoid Arthritis.
Scientific title
A Rising-Single-Dose and Multiple-Dose Safety, Tolerability, and Pharmacokinetic Study of SCH 900117 in Healthy Volunteers and in Subjects with Rheumatoid Arthritis
Secondary ID [1] 283754 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 3840 0
Condition category
Condition code
Inflammatory and Immune System 4030 4030 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 1(Healthy Subjects Only): SCH 900117 12mg, 40mg, 120mg or 400mg. Single dose via subcutaneous injection on Day 1 (Subjects receive only 1 of the 4 possible rising dose levels or placebo. Subjects are randomised to receive active vs placebo).
Part 2 (Rheumatoid Arthritis Patients Only): SCH 900117 400mg. Three subcutaneous doses of study drug or placebo over 3 months (Week 0, Week 4, Week 8). Subjects are randomised to receive either active or placebo.
Intervention code [1] 3566 0
Treatment: Drugs
Comparator / control treatment
Placebo (normal saline).
Part 1: Single dose via subcutaneous injection on Day 1.
Part 2: Three doses subcutaneously over 3 months (Week 0, Week 4, Week 8).
Control group
Placebo

Outcomes
Primary outcome [1] 4930 0
To determine the Safety & Tolerability of SCH 900117 in healthy subjects and patients with Rheumatoid Arthritis.
(Assessed via vital sign measurements, standard laboratory safety tests, urinalysis &/or physical examinations)
Timepoint [1] 4930 0
Assessed throughout the study at each study visit . [Visit schedule Part 1: Daily visits up to Day 7 time point; Day 14; Biweekly until Week 16 (Day 112)] [Visit Schedule Part 2: Daily visits up to Day 7 time point; Day 14; Biweekly until Week 8; Week 9; Week 10; Week 12, Week 16; Monthly until week 24 (D168)]
Secondary outcome [1] 8313 0
To determine the Pharmacokinetics of SCH 900117 in healthy subjects and patients with Rheumatoid Arthritis.
(Assessed via pharmacokinetic blood sampling)
Timepoint [1] 8313 0
Assessed throughout the study at each study visit. [Visit Schedule Part 2: Daily visits up to Day 7 time point; Day 14; Biweekly until Week 8; Week 9; Week 10; Week 12, Week 16; Monthly until week 24 (D168)]

Eligibility
Key inclusion criteria
Part 1-Healthy volunteers

Part 2-Rheumatoid Arthritis >6mths
- >=5 swollen & tender joints
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of malignancy, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C.

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)
Eligible subjects manually assigned an allocation number in sequential order by blinded study staff. Treatment dispensed in a blinded fashion by an unblinded pharmacist based on an unblinded master treatment allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 4020 0
Commercial sector/Industry
Name [1] 4020 0
Schering-Plough
Country [1] 4020 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Schering-Plough
Address
2000 Galloping Hill Road
Kenilworth, New Jersey 07033
Country
United States of America
Secondary sponsor category [1] 3613 0
None
Name [1] 3613 0
Address [1] 3613 0
Country [1] 3613 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6101 0
Ethics committee address [1] 6101 0
Ethics committee country [1] 6101 0
Date submitted for ethics approval [1] 6101 0
22/09/2008
Approval date [1] 6101 0
Ethics approval number [1] 6101 0

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

Contacts
Principal investigator
Name 29046 0
A/Prof Peter Hodsman
Address 29046 0
Nucleus Network 5th Floor Burnet Tower 89 Commercial Road Melbourne VIC 3004
Country 29046 0
Australia
Phone 29046 0
+61 3 9076 8960
Fax 29046 0
Email 29046 0
[email protected]
Contact person for public queries
Name 12203 0
Dr Peter Hodsman
Address 12203 0
Nucleus Network
5th Floor Burnet Tower
89 Commercial Road
Melbourne, VIC 3004
Country 12203 0
Australia
Phone 12203 0
+61 3 90768960
Fax 12203 0
Email 12203 0
[email protected]
Contact person for scientific queries
Name 3131 0
Dr Peter Hodsman
Address 3131 0
Nucleus Network
5th Floor Burnet Tower
89 Commercial Road
Melbourne, VIC 3004
Country 3131 0
Australia
Phone 3131 0
+61 3 90768960
Fax 3131 0
Email 3131 0
[email protected]

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.