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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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12 December 2020 |
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Main ID: |
NCT02565810 |
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Date of registration:
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23/09/2015 |
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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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An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis
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Scientific title:
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An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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49 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02565810 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Poland
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Are male or female aged 18-55 years at the time of signing the informed consent form.
2. Have been diagnosed as having RA according to the revised 1987 American College of
Rheumatology (ACR) criteria for at least 6 months prior to Screening.
3. Subjects who are considered by the Investigator to be a suitable candidate for
self-administering adalimumab treatment
4. Must be able to provide informed consent, which must be obtained prior to any study
related procedures.
Exclusion Criteria:
1. Have been treated previously with any biologic agents including any tumour necrosis
factor inhibitor.
2. Have a known hypersensitivity to human immunoglobulin proteins or other components of
SB5.
3. 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 indicated by a positive
QuantiFERON® Gold test result.
4. Have had a serious infection (such as sepsis, abscess, opportunistic infections or
invasive fungal infection including histoplasmosis) or have been treated with
intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2
weeks prior to first dose of IP. Nonsignificant infections do not need to be
considered exclusionary at the discretion of the Investigator.
5. Have a history of chronic or recurrent infection (such as chronic renal infection,
chronic chest infection or recurrent urinary infection).
6. Have any of the following conditions:
1. History of congestive heart failure (New York Heart Association Class III/IV)
2. History of demyelinating disorders (such as multiple sclerosis or Guillain-Barré
syndrome).
3. History of any malignancy (other than lymphoproliferative disease and melanoma,
see Exclusion Criteria 10.f) within the previous 5 years prior to Screening
except completely excised and cured squamous carcinoma of the uterine cervix,
cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
4. History of lymphoproliferative disease including lymphoma or melanoma.
5. Any other disease or disorder which, in the opinion of the Investigator, will put
the subject at risk if they are enrolled.
Age minimum:
18 Years
Age maximum:
55 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: Adalimumab PFS and Pen
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Primary Outcome(s)
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The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale
[Time Frame: Difference of injection site pain score (Week 6 - Week 2)]
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Secondary Outcome(s)
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Overall Impression of SC Delivery Administration of SB5 Using Questionnaire
[Time Frame: at Week 2 and at Week 6]
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Subject Preference of SC Delivery Administration of SB5 Using Questionnaire
[Time Frame: at Week 6]
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Secondary ID(s)
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SB5-G21-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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