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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00316771




Registration number
NCT00316771
Ethics application status
Date submitted
20/04/2006
Date registered
21/04/2006
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
Scientific title
A Randomized, Double-blind, Placebo-controlled, Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy.
Secondary ID [1] 0 0
PA18439
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - P38 Inhibitor (4) 150mg
Treatment: Drugs - P38 Inhibitor (4) 25mg
Treatment: Drugs - P38 Inhibitor (4) 300mg
Treatment: Drugs - P38 Inhibitor (4) 50mg
Treatment: Drugs - P38 Inhibitor (4) 75mg
Treatment: Drugs - Placebo

Experimental: P38 Inhibitor (4) 150mg -

Experimental: P38 Inhibitor (4) 25mg -

Experimental: P38 Inhibitor (4) 300mg -

Experimental: P38 Inhibitor (4) 50mg -

Experimental: P38 Inhibitor (4) 75mg -

Placebo comparator: Placebo -


Treatment: Drugs: P38 Inhibitor (4) 150mg
150mg po qd

Treatment: Drugs: P38 Inhibitor (4) 25mg
25mg po bid

Treatment: Drugs: P38 Inhibitor (4) 300mg
300mg po qd

Treatment: Drugs: P38 Inhibitor (4) 50mg
50mg po qd

Treatment: Drugs: P38 Inhibitor (4) 75mg
75mg po bid

Treatment: Drugs: Placebo
po bid
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients with ACR 20 response
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of patients with ACR 50/70 response
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Change in ACR core set, DAS 28, HAQ disability index, SF-36, withdrawals, AEs, lab parameters.
Timepoint [2] 0 0
Throughout study

Eligibility
Key inclusion criteria
* adult patients >=18 years of age;
* active rheumatoid arthritis;
* current inadequate clinical response to methotrexate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* receiving any other disease-modifying anti-rheumatic drug, with the exception of hydroxychloroquine or chloroquine.

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 2
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
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
374
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Caboolture
Recruitment hospital [2] 0 0
- Fitzroy
Recruitment hospital [3] 0 0
- Kippa Ring
Recruitment postcode(s) [1] 0 0
4510 - Caboolture
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
4021 - Kippa Ring
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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Florida
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Massachusetts
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Michigan
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North Carolina
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Elblag
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00316771