Study to Test the Safe and Effective Use of an e-Device for the 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

• ClinicalTrials.gov Identifier: NCT03357471
• Recruitment Status: Completed
• First Posted: November 30, 2017
• Results First Posted: October 25, 2019
• Last Update Posted: October 25, 2019
• Sponsor: UCB Biopharma S.P.R.L.
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Moderate and Severe Active Rheumatoid Arthritis; Active Psoriatic Arthritis; Active Ankylosing Spondylitis; Moderately to Severely Active Crohn's Disease	Drug: e-Device	Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: November 3, 2017
• Actual Primary Completion Date: July 2, 2018
• Actual Study Completion Date: July 2, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Certolizumab Pegol Q2W injection by e-Device; Subjects will self-inject Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks.	Drug: e-Device; Active Substance: Certolizumab Pegol; Pharmaceutical form: Solution for injection; Route of administration: subcutaneous injection by e-Device; Other Name: Cimzia
Experimental: Certolizumab Pegol Q4W injection by e-Device; Subjects will self-inject Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks.	Drug: e-Device; Active Substance: Certolizumab Pegol; Pharmaceutical form: Solution for injection; Route of administration: subcutaneous injection by e-Device; Other Name: Cimzia

Outcome Measures

Primary Outcome Measures :

1. Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 2 [ 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:

   • Dose Delivery: Subject self-injected the complete dose of Certolizumab Pegol (CZP) as confirmed by a visual inspection of the CZP-cassette(s) which shows the pre-filled syringe container to be empty AND
   • No Adverse Events related to use of the e-Device (Adverse Device Effects) that would preclude continued use of the e-Device for self-injection.

   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.

Secondary Outcome Measures :

1. Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 1 [ Time Frame: Visit 1 (Week 0) ]

   Safe and effective self-injection was evaluated by the healthcare provider and is defined as:

   • Dose Delivery: Subject self-injected the complete dose of Certolizumab Pegol (CZP) as confirmed by a visual inspection of the CZP-cassette(s) which shows the pre-filled syringe container to be empty AND
   • No Adverse Events related to use of the e-Device (Adverse Device Effects) that would preclude continued use of the e-Device for self-injection.

   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.

2. Percentage of Used Certolizumab Pegol (CZP)-Cassettes Identified as Having Structural Integrity Issues Based on Visual Examination [ 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.
3. Mean Change From Baseline in Systolic Blood Pressure [ 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).
4. Mean Change From Baseline in Diastolic Blood Pressure [ 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).
5. Mean Change From Baseline in Pulse Rate [ 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).
6. Mean Change From Baseline in Respiratory Rate [ 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).
7. Mean Change From Baseline in Body Temperature [ Time Frame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W) ]
   Body Temperature was measured in Grad Celsius (°C).
8. Incidence of Adverse Events (AEs) During the Study [ 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.
9. Incidence of Adverse Device Events (ADEs) During the Study [ 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:

   • Adverse event that resulted from insufficiencies or inadequacies in the Instructions for Use (IFU), the deployment, the implantation, the installation, the operation, or any malfunction of the investigational medical device
   • Adverse event that was a result of an error or intentional misuse.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Subject is male or female and must be at least 18 years old at Visit 1
• Subject must have been diagnosed at least 6 months prior to Visit 1 with documented moderate to severe active Rheumatoid Arthritis (RA), active Psoriatic Arthritis (PsA), active Ankylosing Spondylitis (AS) (in US), or moderately to severely active Crohn's Disease (CD) (in US)
• A minimum of 10 subjects will have impaired hand function. Impaired hand function will be measured using the Cochin scale (Duruöz et al, 1996; Poiraudeau et al, 2000) and impaired hand function will be defined as patients who have a Cochin score >= 13.5 at Baseline
• Subjects must have been prescribed Certolizumab Pegol (CZP) and must have been self-injecting CZP using the pre-filled syringe for at least 3 months prior to Visit 1. Subjects with RA, PsA, or AS must have been on a stable Q2W (every 2 weeks) or Q4W (every 4 weeks) CZP dosing regimen for at least 3 months prior to Screening. Subjects with CD must have been on a stable Q4W CZP dosing regimen for at least 3 months prior to Visit 1.
• Subjects must have been screened according to the applicable national tuberculosis (TB) screening guidelines (to be documented) or provide a documented TB screening activity (TB questionnaire, Interferon-Gamma-Release Assay (IGRA) test, or chest x-ray) within the past 12 months prior to Visit 1.
• Female subjects of childbearing potential should have a negative pregnancy test at Visit 1 and should be using a medically accepted method of contraception during the entire duration of the study. Female subjects who are postmenopausal for at least 2 years or have undergone a complete hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy, or have a congenital sterility are considered not of childbearing potential

Exclusion Criteria:

• Subject has participated in another study of an investigational medicinal product (IMP) or an investigational device within the previous 3 months or is currently participating in another study of an IMP or an investigational device
• Subject has a history of chronic alcohol or drug abuse within the previous 6 months
• Subject has a history of significant cardiovascular, respiratory, gastrointestinal, hepatic, endocrine, renal, dermatological, neurological, psychiatric, hematological, or bleeding disorders
• Subjects with known Tuberculosis (TB) infection and at high risk of acquiring TB infection. Subjects with latent TB (LTB) who have not completed the prophylactic treatment regimen for LTB 3 months prior to enrollment
• Subject has an active chronic/latent infection including but not limited to TB (untreated latent or active), hepatitis virus (HV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
• Subject has a current malignancy or a history of malignancy. Subjects with less than 3 completely excised basal cell carcinomas or with cervical carcinoma in situ successfully treated surgically more than 5 years prior to Screening may be included
• Subject has had major surgery (including joint surgery) within 8 weeks prior to Visit 1, or has a scheduled surgery during the study

Contacts and Locations

Locations

United States, Arizona

Ra0098 116

Mesa, Arizona, United States, 85202

Ra0098 107

Mesa, Arizona, United States, 85306

Ra0098 135

Phoenix, Arizona, United States, 85037

Ra0098 119

Tucson, Arizona, United States, 85704

United States, California

Ra0098 101

Covina, California, United States, 91722

United States, Florida

Ra0098 131

Clermont, Florida, United States, 34711

Ra0098 132

Coral Springs, Florida, United States, 33071

United States, Georgia

Ra0098 127

Gainesville, Georgia, United States, 30501

United States, Iowa

Ra0098 122

Clive, Iowa, United States, 50265

United States, Missouri

Ra0098 105

Saint Louis, Missouri, United States, 63110

Ra0098 104

Saint Louis, Missouri, United States, 63128

United States, New Jersey

Ra0098 103

Dover, New Jersey, United States, 07801

United States, New York

Ra0098 117

Great Neck, New York, United States, 11021

United States, South Carolina

Ra0098 113

Myrtle Beach, South Carolina, United States, 29572

United States, Tennessee

Ra0098 126

Hixson, Tennessee, United States, 37343

United States, Texas

Ra0098 111

Austin, Texas, United States, 78731

Ra0098 123

Austin, Texas, United States, 78745

Ra0098 102

Austin, Texas, United States, 78758

Ra0098 128

Corpus Christi, Texas, United States, 78404

Ra0098 106

Nassau Bay, Texas, United States, 77058

Ra0098 114

San Antonio, Texas, United States, 78229

United States, Washington

Ra0098 133

Richland, Washington, United States, 99352

Sponsors and Collaborators

UCB Biopharma S.P.R.L.

Investigators

• Study Director: UCB Cares; 001 844 599 2273 (UCB)

  Study Documents (Full-Text)

Documents provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):

Study Protocol  [PDF] September 29, 2017

Statistical Analysis Plan  [PDF] November 17, 2017

More Information

Additional Information:

FDA Safety Alerts and Recalls 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pompilus F, Ciesluk A, Strzok S, Ciaravino V, Harris K, Szegvari B, Mountian I, Cleanthous S, Meunier J. Development and psychometric evaluation of the assessment of self-injection questionnaire: an adaptation of the self-injection assessment questionnaire. Health Qual Life Outcomes. 2020 Nov 4;18(1):355. doi: 10.1186/s12955-020-01606-7.

• Responsible Party: UCB Biopharma S.P.R.L.
• ClinicalTrials.gov Identifier: NCT03357471
• Other Study ID Numbers: RA0098
• First Posted: November 30, 2017
• Results First Posted: October 25, 2019
• Last Update Posted: October 25, 2019
• Last Verified: October 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):

Certolizumab Pegol; E-Device

Additional relevant MeSH terms:

Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing; Crohn Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Spondylarthropathies; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Bone Diseases, Infectious; Infections; Axial Spondyloarthritis; Ankylosis