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Trial registered on ANZCTR


Registration number
ACTRN12608000644369
Ethics application status
Approved
Date submitted
5/12/2008
Date registered
18/12/2008
Date last updated
18/12/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of BG00012 when given with methotrexate to subjects with active rheumatoid arthritis who have had an inadequate response to conventional disease-modifying anti-rheumatic drug therapy.
Scientific title
A Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of BG00012 when given with methotrexate to subjects with active rheumatoid arthritis who have had an inadequate response to conventional disease-modifying anti-rheumatic drug therapy.
Secondary ID [1] 763 0
EUDRA CT No. 2008-004754-33
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 4067 0
Condition category
Condition code
Inflammatory and Immune System 4274 4274 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention (All groups)
Methotrexate as a stabilised treatment regimen between greater than or equal to 7.5mg per week to less than or equal to 25mg per week, as prescribed by their rheumatologist or general care physician. Dosage form either oral or injectable but cannot change through week 12. The dosage may be decreased if required due to toxicity.

Intervention Group 1
BG00012 240 mg twice daily orally and placebo once daily orally for 12 weeks

Intervention Group 2
BG00012 240 mg 3 times daily orally for 12 weeks
Intervention code [1] 3787 0
Treatment: Drugs
Comparator / control treatment
Intervention (All groups)
Methotrexate as a stabilised treatment regimen between greater than or equal to 7.5mg per week to less than or equal to 25mg per week, as prescribed by their rheumatologist or general care physician. Dosage form either oral or injectable but cannot change through week 12. The dosage may be decreased if required due to toxicity.

Control group
Placebo sugar capsule (contains lactose) 3 times daily orally for 12 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 5159 0
Primary outcome: clinical efficacy of BG00012 with methotrexate; specifically, the American College of Rheumatology (ACR20) response. To achieve ACR20 response, a 20% improvement compared to baseline is required for both
swollen and tender joint counts, as well as 3 out of 5 additional parameters: Subject's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, subject's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and high sensitivity C-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).
Timepoint [1] 5159 0
Baseline and at 12 weeks
Secondary outcome [1] 8678 0
The proportion of subjects with an American College of Rheumatology (ACR50 and ACR70) response grading
Timepoint [1] 8678 0
Baseline and 12 weeks
Secondary outcome [2] 8679 0
Changes from baseline in the individual ACR core set parameters including swollen and tender joint counts, Subject/Investigator Global Assessment of disease activity, Health Assessment Questionnaire-Disability Index and subject's assessment of pain.
Timepoint [2] 8679 0
Baseline and 12 weeks
Secondary outcome [3] 8680 0
the proportion of subjects with a categorical Disease Activity Score, 28-joint version
(DAS28) response (European League Against Rheumatism [EULAR] response)
Timepoint [3] 8680 0
Baseline and at 12 weeks
Secondary outcome [4] 8681 0
the change from baseline Disease Activity Score, 28-joint version (DAS28)
Timepoint [4] 8681 0
Baseline and at 12 weeks
Secondary outcome [5] 8682 0
the change from baseline in Quality of Life measures including; Health Assessment Quesstionnaire Disability Index, Short Form 36 questionnaire (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire (FACIT-F)
Timepoint [5] 8682 0
Baseline and at 12 weeks
Secondary outcome [6] 8683 0
To determine the safety of BG00012 with methotrexate in this population. Measures include; physical examinations, vital signs, electrocardiogram (ECG), laboratory parameters including haematology, blood chemistry and urinalysis and monitoring for adverse events, serious adverse events and concomitant therapies.
Timepoint [6] 8683 0
Baseline and at 12 weeks
Secondary outcome [7] 8804 0
To determine the tolerability of BG00012 with methotrexate in this population. Measures include; physical examinations, vital signs, electrocardiogram (ECG), laboratory parameters including haematology, blood chemistry and urinalysis and monitoring for adverse events, serious adverse events and concomitant therapies.
Timepoint [7] 8804 0
Baseline and at 12 weeks

Eligibility
Key inclusion criteria
- Written informed consent
- Diagnosis of adult onset RA according to the 1987 Revised American Rheumatism Association Criteria for the Classification of Rheumatoid Arthritis (Functional Class I – III)(Section22, Appendix A) for at least 6 months prior to Day 0.
- Must have been treated with, and be tolerating, methotrexate for at least 3 months immediately prior to Day 0. The dose of mthotrexate must be stable for at least 4 weeks prior to Day 0.
- All subjects of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 1 month after their last dose of study treatment.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical History
1. Subjects with a history of malignant disease, including solid tumors and haematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
2. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
3. History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal or hematologic insufficiency, or any major disease that could affect any of the efficacy assessments, in particular, joint pain and swelling (e.g., Parkinson’s disease, cerebral palsy, diabetic neuropathy).
4. Known active bacterial, viral, fungal, mycobacterial, opportunistic infection or other infection (including atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of Day 0.
5. Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study.
Treatment History
6. Other clinical issues or laboratory results that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.

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)
Randomization will take place across all study sites using a centralized Interactive Voice Response System.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will take place across all study sites using a centralized Interactive Voice Response System. Subjects will be randomized after the Investigator has verified that they are eligible. Randomization will be stratified by screening rheumatoid factor (RF) status and region. Subjects will be randomized to receive placebo, BG00012 480 mg/day, or BG00012 720 mg/day. Subjects who are withdrawn from the study may be replaced.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1341 0
5011
Recruitment postcode(s) [2] 1350 0
4102
Recruitment outside Australia
Country [1] 1427 0
India
State/province [1] 1427 0

Funding & Sponsors
Funding source category [1] 4254 0
Commercial sector/Industry
Name [1] 4254 0
Biogen Idec, Inc
Country [1] 4254 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Biogen Idec, Inc
Address
14 Cambridge Center
Cambridge, MA 02142
Country
United States of America
Secondary sponsor category [1] 3827 0
Commercial sector/Industry
Name [1] 3827 0
Biogen Idec Australia
Address [1] 3827 0
Suite 2, Level 4
123 Epping Road
North Ryde NSW 2113
Country [1] 3827 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 29196 0
Address 29196 0
Country 29196 0
Phone 29196 0
Fax 29196 0
Email 29196 0
Contact person for public queries
Name 12353 0
Dr Atsumi Fukui
Address 12353 0
Biogen Idec Australia
Suite 2, Level 4
123 Epping Road
North Ryde NSW 2113
Country 12353 0
Australia
Phone 12353 0
+61288753900
Fax 12353 0
+61298891162
Email 12353 0
[email protected]
Contact person for scientific queries
Name 3281 0
Dr Atsumi Fukui
Address 3281 0
Biogen Idec Australia
Suite 2, Level 4
123 Epping Road
North Ryde NSW 2113
Country 3281 0
Australia
Phone 3281 0
+61288753900
Fax 3281 0
+61298891162
Email 3281 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

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Documents added automatically
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