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

NCT03357471 | Completed Phase 3 Results FDA Drug

• 1 other identifier: RA0098
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 22

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.

Conditions

Moderate and Severe Active Rheumatoid Arthritis; Active Psoriatic Arthritis; Active Ankylosing Spondylitis; Moderately to Severely Active Crohn's Disease

Keywords

Certolizumab Pegol; E-Device

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 2

  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.

  Visit 2 (Week 2 for Q2W; Week 4 for Q4W)

Secondary Outcomes (9)

• Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 1

  Visit 1 (Week 0)

• Percentage of Used Certolizumab Pegol (CZP)-Cassettes Identified as Having Structural Integrity Issues Based on Visual Examination

  During the study (from Week 0 up to Week 4)

• Mean Change From Baseline in Systolic Blood Pressure

  From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)

• Mean Change From Baseline in Diastolic Blood Pressure

  From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)

• Mean Change From Baseline in Pulse Rate

  From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)

Study Arms (2)

Certolizumab Pegol Q2W injection by e-Device

EXPERIMENTAL

Subjects will self-inject Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks.

Drug: e-Device

Certolizumab Pegol Q4W injection by e-Device

EXPERIMENTAL

Subjects will self-inject Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks.

Drug: e-Device

Interventions

e-Device DRUG

* Active Substance: Certolizumab Pegol * Pharmaceutical form: Solution for injection * Route of administration: subcutaneous injection by e-Device

Also known as: Cimzia

Certolizumab Pegol Q2W injection by e-Device; Certolizumab Pegol Q4W injection by e-Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (22)

Ra0098 116

Mesa, Arizona, 85202, United States

Location

Ra0098 107

Mesa, Arizona, 85306, United States

Location

Ra0098 135

Phoenix, Arizona, 85037, United States

Location

Ra0098 119

Tucson, Arizona, 85704, United States

Location

Ra0098 101

Covina, California, 91722, United States

Location

Ra0098 131

Clermont, Florida, 34711, United States

Location

Ra0098 132

Coral Springs, Florida, 33071, United States

Location

Ra0098 127

Gainesville, Georgia, 30501, United States

Location

Ra0098 122

Clive, Iowa, 50265, United States

Location

Ra0098 105

St Louis, Missouri, 63110, United States

Location

Ra0098 104

St Louis, Missouri, 63128, United States

Location

Ra0098 103

Dover, New Jersey, 07801, United States

Location

Ra0098 117

Great Neck, New York, 11021, United States

Location

Ra0098 113

Myrtle Beach, South Carolina, 29572, United States

Location

Ra0098 126

Hixson, Tennessee, 37343, United States

Location

Ra0098 111

Austin, Texas, 78731, United States

Location

Ra0098 123

Austin, Texas, 78745, United States

Location

Ra0098 102

Austin, Texas, 78758, United States

Location

Ra0098 128

Corpus Christi, Texas, 78404, United States

Location

Ra0098 106

Nassau Bay, Texas, 77058, United States

Location

Ra0098 114

San Antonio, Texas, 78229, United States

Location

Ra0098 133

Richland, Washington, 99352, United States

Location

Related Publications (1)

• 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.

  PMID: 33148261 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844 599

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: November 30, 2017
• Study Start: November 3, 2017
• Primary Completion: July 2, 2018
• Study Completion: July 2, 2018
• Last Updated: October 25, 2019
• Results First Posted: October 25, 2019

Record last verified: 2019-10

Locations

US (22)