AzTrials
AzTrials

Moderate and Severe Active Rheumatoid ArthritisPhase 3NCT03357471

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

A Phase 3 study testing e-Device in people with Moderate and Severe Active Rheumatoid Arthritis and Active Psoriatic Arthritis, run by UCB Biopharma S.P.R.L. at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
e-Device
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
22 sitesUnited States
Study dates
3 Nov 2017to 2 Jul 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Ra0098 111

    Austin, Texas, 78731

  • Ra0098 123

    Austin, Texas, 78745

  • Ra0098 102

    Austin, Texas, 78758

  • Ra0098 131

    Clermont, Florida, 34711

  • Ra0098 122

    Clive, Iowa, 50265

  • Ra0098 132

    Coral Springs, Florida, 33071

  • Ra0098 128

    Corpus Christi, Texas, 78404

  • Ra0098 101

    Covina, California, 91722

  • Ra0098 103

    Dover, New Jersey, 07801

  • Ra0098 127

    Gainesville, Georgia, 30501

  • Ra0098 117

    Great Neck, New York, 11021

  • Ra0098 126

    Hixson, Tennessee, 37343

  • Ra0098 116

    Mesa, Arizona, 85202

  • Ra0098 107

    Mesa, Arizona, 85306

  • Ra0098 113

    Myrtle Beach, South Carolina, 29572

  • Ra0098 106

    Nassau Bay, Texas, 77058

  • Ra0098 135

    Phoenix, Arizona, 85037

  • Ra0098 133

    Richland, Washington, 99352

  • Ra0098 114

    San Antonio, Texas, 78229

  • Ra0098 105

    St Louis, Missouri, 63110

  • Ra0098 104

    St Louis, Missouri, 63128

  • Ra0098 119

    Tucson, Arizona, 85704

Other trials in United States

About this study

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

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.

Being tested
e-Device
Keywords
Certolizumab Pegol, E-Device
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-DeviceDrug

    Also called Cimzia

    • Active Substance: Certolizumab Pegol
    • Pharmaceutical form: Solution for injection
    • Route of administration: subcutaneous injection by e-Device
Study groups in NCT03357471
Study groupRoleWhat they receive
Certolizumab Pegol Q2W injection by e-DeviceExperimentalSubjects will self-inject Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks.
Receives: Drug: e-Device
Certolizumab Pegol Q4W injection by e-DeviceExperimentalSubjects will self-inject Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks.
Receives: Drug: e-Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (9)

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

    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.

    Measured: Visit 1 (Week 0)

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

    CZP-cassettes identified as having structural integrity issues meant CZP-cassettes with clear evidence of damage/compromised structural integrity, not superficial cosmetic imperfections.

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

  3. Mean Change From Baseline in Systolic Blood Pressure

    Blood pressure was measured in millimetre of mercury (mmHg).

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

  4. Mean Change From Baseline in Diastolic Blood Pressure

    Blood pressure was measured in millimetre of mercury (mmHg).

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

  5. Mean Change From Baseline in Pulse Rate

    Pulse Rate was measured in beats per minute (beats/min).

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

  6. Mean Change From Baseline in Respiratory Rate

    Respiratory Rate was measured in breaths per minute (breaths/min).

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

  7. Mean Change From Baseline in Body Temperature

    Body Temperature was measured in Grad Celsius (°C).

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

  8. Incidence of Adverse Events (AEs) During the Study

    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.

    Measured: During the study (from Week 0 up to Week 5 +/-3 Days)

  9. Incidence of Adverse Device Events (ADEs) During the Study

    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.

    Measured: During the study (from Week 0 up to Week 5 +/-3 Days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2017
  2. Study start3 Nov 2017
  3. Primary completion2 Jul 2018
  4. Study completion2 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03357471
Sponsor's protocol ID
RA0098
Status last verified
Oct 2019
First submitted
23 Nov 2017
Last updated
25 Oct 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • 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.

    PubMed 33148261

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing e-Device in people with Moderate and Severe Active Rheumatoid Arthritis and Active Psoriatic Arthritis, run by UCB Biopharma S.P.R.L. at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03357471, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in