e-Device
Drug- Active Substance: Certolizumab Pegol
- Pharmaceutical form: Solution for injection
- Route of administration: subcutaneous injection by e-Device
Other names: Cimzia
NCT Number: NCT03357471
The purpose of the study is to evaluate the ability of subjects who are already prescribed Certolizumab Pergol therapy and have been self injecting with prefilled syringes for at least the previous three months, to safely and effectively self-inject Certolizumab Pegol (CZP) using the e-Device and to evaluate the post-use structural integrity of used devices and cassettes via visual examination.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Ra0098 107, Mesa, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Cimzia
Time frame: Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
Safe and effective self-injection was evaluated by the healthcare provider and is defined as:
For subjects on the Q4W (every 4 weeks) dosing regimen who would self-inject twice (2×200 mg CZP) at each visit, each injection was evaluated for safety and effectiveness using the above criteria. The primary endpoint of safe and effective self-injection for subjects on the Q4W dosing regimen was met only if both self-injections were determined to be safe and effective.
Time frame: Visit 1 (Week 0)
Safe and effective self-injection was evaluated by the healthcare provider and is defined as:
For subjects on the Q4W (every 4 weeks) dosing regimen who would self-inject twice (2×200 mg CZP) at each visit, each injection was evaluated for safety and effectiveness using the above criteria. The primary endpoint of safe and effective self-injection for subjects on the Q4W dosing regimen was met only if both self-injections were determined to be safe and effective.
Time frame: During the study (from Week 0 up to Week 4)
CZP-cassettes identified as having structural integrity issues meant CZP-cassettes with clear evidence of damage/compromised structural integrity, not superficial cosmetic imperfections.
Time frame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
Blood pressure was measured in millimetre of mercury (mmHg).
Time frame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
Blood pressure was measured in millimetre of mercury (mmHg).
Time frame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
Pulse Rate was measured in beats per minute (beats/min).
Time frame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
Respiratory Rate was measured in breaths per minute (breaths/min).
Time frame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
Body Temperature was measured in Grad Celsius (°C).
Time frame: During the study (from Week 0 up to Week 5 +/-3 Days)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product (IMP), whether or not related to the medicinal (investigational) product.
Time frame: During the study (from Week 0 up to Week 5 +/-3 Days)
An Adverse Device Event (ADE) was an AE related to the use of an investigational device. An ADE must have met 1 or more of the following criteria:
UCB Biopharma S.P.R.L.
Industry
A Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous Self-Injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04876781
Active Ankylosing Spondylitis, Active Moderate to Severe Rheumatoid Arthritis
Seoul, South Korea
View Trial DetailsNCT05212051
Active Ankylosing Spondylitis
Hefei, Anhui, China
View Trial DetailsNCT05504811
Brain Diseases, Central Nervous System Diseases
Downey, California, United States
View Trial DetailsNCT03568461
Disease Attributes, Follicular Lymphoma
Duarte, California, United States
View Trial Details