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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/NCT00810836




Registration number
NCT00810836
Ethics application status
Date submitted
17/12/2008
Date registered
18/12/2008
Date last updated
16/09/2013

Titles & IDs
Public title
Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis
Scientific title
A Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of BG00012 When Given With Methotrexate to Subjects With Active RA Who Have Had an Inadequate Response to Conventional Disease-Modifying Anti-rheumatic Drug Therapy
Secondary ID [1] 0 0
109RA201
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 - BG00012
Treatment: Drugs - BG00012
Treatment: Drugs - placebo

Active Comparator: 1 - BG00012 480 mg/day

Active Comparator: 2 - BG00012 720 mg/day

Placebo Comparator: 3 -


Treatment: Drugs: BG00012
oral

Treatment: Drugs: BG00012
Oral

Treatment: Drugs: placebo
oral placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12.
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
To determine the safety and tolerability of BG00012 with methotrexate in this population.
Timepoint [1] 0 0
12 weeks

Eligibility
Key inclusion criteria
- must be taking methotrexate

- inadequate response to at least one conventional DMARD

- swollen and tender joint count
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- previous treatment with TNF or any other biologic or prosorba column

Other criteria also apply.

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 administering the treatment/s
The people assessing the outcomes
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
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2010
Sample size
Target
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Research Site - Woolloongabba
Recruitment hospital [2] 0 0
Research Site - Woodville
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
New Market
Country [3] 0 0
Canada
State/province [3] 0 0
Ottawa
Country [4] 0 0
Canada
State/province [4] 0 0
Rothesay
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Active, not recruiting
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Pardubice
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Uh. Hradiste
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Zlin
Country [9] 0 0
India
State/province [9] 0 0
Bangalore
Country [10] 0 0
India
State/province [10] 0 0
Hyderabaad
Country [11] 0 0
India
State/province [11] 0 0
Hyderabad
Country [12] 0 0
India
State/province [12] 0 0
Lucknow
Country [13] 0 0
Poland
State/province [13] 0 0
Bialystock
Country [14] 0 0
Poland
State/province [14] 0 0
Grodzisk Mazowiecki
Country [15] 0 0
Poland
State/province [15] 0 0
Lublin
Country [16] 0 0
Poland
State/province [16] 0 0
Poznan
Country [17] 0 0
Poland
State/province [17] 0 0
Torun
Country [18] 0 0
Poland
State/province [18] 0 0
Warsaw
Country [19] 0 0
Poland
State/province [19] 0 0
Warszawa
Country [20] 0 0
Slovakia
State/province [20] 0 0
Banska Bysterica
Country [21] 0 0
Slovakia
State/province [21] 0 0
Bratislava
Country [22] 0 0
Slovakia
State/province [22] 0 0
Kosice
Country [23] 0 0
Slovakia
State/province [23] 0 0
Piestany

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms
of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who
still suffer symptoms of RA. The purpose is also to ensure that the combination of
methotrexate is safe for patients to take and that any side effects are acceptable to
patients with RA.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00810836
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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