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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02167139 |
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Date of registration:
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16/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
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Scientific title:
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A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis |
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Date of first enrolment:
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May 2014 |
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Target sample size:
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544 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02167139 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Lithuania
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Poland
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Contacts
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Name:
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Asta Baranauskaite, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital of Lithuanian University of Health Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Are male or female aged 18-75 years at the time of signing the informed consent form.
- Have been diagnosed as having RA according to the revised 1987 American College of
Rheumatology (ACR) criteria for at least 6 months but not exceeding 15 years prior to
Screening.
- Have moderate to severe active disease despite MTX therapy defined as:
1. More than or equal to six swollen joints and more than or equal to six tender
joints (from the 66/68 joint count system) at Screening and Randomisation.
2. Either erythrocyte sedimentation rate (Westergren) = 28 mm/h or serum C-reactive
protein = 10 mg/dL at Screening.
- Must have been treated with MTX for a total of at least 6 months prior to
Randomisation and must have been on both: a stable route of administration (oral or
parenteral) and stable dose of MTX (10-25 mg/week) for at least 4 weeks prior to
Screening.
- Female subjects who are not pregnant or nursing at Screening and Randomisation and who
are not planning to become pregnant from Screening until 5 months after the last dose
of IP.
Exclusion Criteria:
- Have been treated previously with any biological agents including any tumour necrosis
factor inhibitor.
- Have a known hypersensitivity to human immunoglobulin proteins or other components of
Humira or SB5.
- Have a positive serological test for hepatitis B or hepatitis C or have a known
history of infection with human immunodeficiency virus.
- Have a current diagnosis of active tuberculosis (TB), have been recently exposed to a
person with active TB, or are considered to have latent TB.
- Have had a serious infection or have been treated with intravenous antibiotics for an
infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.
- Have a history of chronic or recurrent infection.
- Have any of the following conditions:
1. History of congestive heart failure (New York Heart Association Class III/IV).
2. History of acute myocardial infarction or unstable angina within the previous 12
months prior to Screening.
3. History of demyelinating disorders.
4. History of any malignancy within the previous 5 years prior to Screening.
5. History of lymphoproliferative disease including lymphoma.
6. Any other disease or disorder which, in the opinion of the Investigator, will put
the subject at risk if they are enrolled.
- Have physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Humira (adalimumab)
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Drug: SB5 (proposed biosimilar to adalimumab)
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Primary Outcome(s)
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American College of Rheumatology 20% Response Criteria (ACR20)
[Time Frame: Week 24]
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Secondary Outcome(s)
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Disease Activity Score Based on a 28 Joint Count (DAS28)
[Time Frame: Week 24, Week 52]
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American College of Rheumatology 50% Response Criteria (ACR50)
[Time Frame: Week 24, Week 52]
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ACR20
[Time Frame: Week 52]
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Secondary ID(s)
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SB5-G31-RA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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