|E.1 Medical condition or disease under investigation
|Medical condition(s) being investigated
|Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC).
|Medical condition in easily understood language
|Diseases [C] - Musculoskeletal Diseases [C05]
|E.1.2 Medical condition or disease under investigation
|System Organ Class
|10028395 - Musculoskeletal and connective tissue disorders
|Condition being studied is a rare disease
|E.2 Objective of the trial
|Main objective of the trial
|The primary objective of this study is to demonstrate the comparability between subcutaneous (SC) delivery administration of SB5 via the pre-filled pen (Pen) versus the pre-filled syringe (PFS) in terms of injection site pain in subjects with rheumatoid arthritis (RA).
|Secondary objectives of the trial
|The secondary objectives are:
• To assess the usability between SC delivery administration of SB5 via Pen versus PFS
• To assess the safety of SB5 via Pen and PFS
|Trial contains a sub-study
|Principal 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 selfadministering adalimumab treatment
4. Must be able to provide informed consent, which must be obtained prior to any study related procedures.
|Principal 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:
a. History of congestive heart failure (New York Heart Association Class III/IV)
b. History of demyelinating disorders (such as multiple sclerosis or Guillain-Barré syndrome).
c. 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.
d. History of lymphoproliferative disease including lymphoma or melanoma.
e. Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.
|E.5 End points
|Primary end point(s)
|Injection site pain evaluation
|Timepoint(s) of evaluation of this end point
|Secondary end point(s)
|• Overall impression of SC delivery administration of SB5 using questionnaire at Weeks 2 and 6
• Subject preference of SC delivery administration of SB5 using questionnaire at Week 6
• Incidence of AEs (graded as mild, moderate, and severe)
• Incidence of serious AEs (SAEs)
• Injection site assessment
• Clinical laboratory value
• Physical examination
• Vital signs
|Timepoint(s) of evaluation of this end point
|Overall impression - at Weeks 2 and 6
Subject preference - at Week 6
Safety endpoints - during the trial
|E.6 and E.7 Scope of the trial
|Scope of the trial
|Other scope of the trial description
|Usability, the primary usability analysis will aim to show the equivalence in terms of injection site pain score
|Trial type and phase
|Human pharmacology (Phase I)
|First administration to humans
|Other trial type description
|Therapeutic exploratory (Phase II)
|Therapeutic confirmatory (Phase III)
|Therapeutic use (Phase IV)
|E.8 Design of the trial
| Comparator of controlled trial
|Other medicinal product(s)
|Number of treatment arms in the trial
The trial involves single site in the Member State concerned
| The trial involves multiple sites in the Member State concerned
|Number of sites anticipated in Member State concerned
|The trial involves multiple Member States
|E.8.6 Trial involving sites outside the EEA
|Trial being conducted both within and outside the EEA
|Trial being conducted completely outside of the EEA
|Trial has a data monitoring committee
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|E.8.9 Initial estimate of the duration of the trial
|In the Member State concerned years
|In the Member State concerned months
|In the Member State concerned days