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Rheumatoid ArthritisPhase 3RAPID-C OLENCT02319642

An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044

A Phase 3 study testing Certolizumab Pegol in people with Rheumatoid Arthritis, run by UCB Pharma SA at 30 sites in China.

Completed

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

Official record
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Trial summary

This study will continue to evaluate the safety \& efficacy of Certolizumab Pegol (CZP) for 6 months in Chinese subjects with active Rheumatoid Arthritis who participated in RA0044. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Certolizumab Pegol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
347 participants
Where
30 sitesChina
Study dates
Nov 2014to Dec 2016
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

  • An Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) for RA0078 is signed and dated by the subject or by the parent(s) or legal representative
  • Subject/ legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
  • Subjects must either have:
  • Completed RA0044 through Week 24, OR
  • Failed to achieve an ACR20 response at Week 12 (confirmed at Week 14) in RA0044
  • Subjects must have complied with the protocol requirements during their participation in RA0044
Show all 9Show fewer
  • Subjects entering RA0078 who have completed RA0044 must have a clear chest x-ray at the Week 24 Completion Visit of RA0044. Subjects who enter RA0078 at Week 16 of the RA0044 study are not required to have a chest x-ray prior to enrollment
  • Subject is able to continue treatment with Methotrexate (MTX) (with or without folic acid) at a dose deemed appropriate by the Investigator
  • Female subjects with childbearing potential should have a negative pregnancy test at Entry and should have a medically accepted method of contraception used during the entire duration of the study and for 10 weeks after the last dose of Certolizumab pegol (CZP). Medically accepted methods of contraception are: hormonal contraception for at least 2 cycles prior to Screening, intrauterine device, implant device, diaphragm with spermicide, bilateral tubal ligation, monogamous relationship with vasectomized (for at least 3 months prior to Screening) partner, or using condoms with spermicide gel. Abstinence is not an acceptable method of contraception for the study. Female subjects who are postmenopause for at least 2 years or had undergone a complete hysterectomy, bilateral tubal ligation and/ or bilateral ovariectomy, or have a congenital sterility are considered not of childbearing potential. Male subjects must agree to ensure they use adequate contraception during the study and for at least 10 weeks after the subject receives their last dose of study medication

Who cannot join

  • Rheumatoid Arthritis (RA) disease-related exclusions:
  • Subjects have a diagnosis of any other inflammatory arthritis eg, psoriatic arthritis or ankylosing spondylitis
  • Subjects have a secondary, noninflammatory type of arthritis (eg, osteoarthritis or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CZP on the subject's primary diagnosis of RA
  • Subjects have a history of an infected joint prosthesis at any time with that prosthesis still in situ
  • Concomitant medication exclusions
  • Subjects must be free of the following concomitant medications:
Show all 26Show fewer
  • Any biological therapy for RA
  • Any experimental therapy, within or outside a clinical trial (except RA0044)
  • Live vaccines Medical history exclusions
  • Lactating and/or pregnant female subjects
  • Male subjects with childbearing potential partner(s) and female subjects of childbearing potential who are NOT practicing effective birth control. All female subjects must test negative on a urine pregnancy test before study entry and at each study visit
  • Subjects with known TB infection, at high risk of acquiring TB infection, or latent TB (LTB) infection (with exception) are excluded
  • Subjects who had 3 or more infections requiring systemic antibiotics during RA0044
  • Subjects with a history of chronic infection, recent serious or life-threatening infection (within 6 months, including herpes zoster), or a current sign or symptom that may indicate an infection (eg, fever, cough)
  • Subjects with a history or active systemic/ respiratory infection due to fungal, parasitic, or mycotic pathogens including but not limited to histoplasmosis, coccidiosis, paracoccidiosis, pneumocystis, blastomyces, aspergillus, and nontuberculous mycobacteria (NTMB)
  • Radiographic evidence suggestive of any of these infections is sufficient grounds for exclusion
  • Subjects at a high risk of infection in the Investigator's opinion (eg, subjects with leg ulcers, indwelling urinary catheter, and persistent or recurrent chest infections, and subjects who are permanently bedridden or wheelchair bound)
  • Subjects with a known positive hepatitis B surface antigen (HBsAg) test and/ or hepatitis C virus antibody (anti-HCV) test result
  • Subjects with known human immunodeficiency virus (HIV) infection
  • Subjects with lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time
  • Subjects with active malignancy of any type
  • Subjects with a history of blood dyscrasias, eg, leukemia or hemophilia where the blood constituents are abnormal or are present in abnormal quantity.
  • Subjects with class III or IV congestive heart failure New York Heart Association (NYHA) 1994
  • Subjects with suspected or diagnosed demyelinating disease of the central nervous system (eg, multiple sclerosis or optic neuritis)
  • Subjects with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the subject's participation in the study. Abnormal laboratory parameters that require exclusion of a subject are detailed in protocol
  • Subjects with an adverse reaction to Percutaneous Endoscopic Gastrostomy (PEG) or a protein medicinal product or known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

China30 sites

  • 037

    Baotou

  • 001

    Beijing

  • 002

    Beijing

  • 013

    Beijing

  • 021

    Beijing

  • 025

    Beijing

  • 033

    Beijing

  • 014

    Bengbu

  • 034

    Changchun

  • 017

    Changsha

  • 019

    Changsha

  • 007

    Chengdu

  • 012

    Chengdu

  • 004

    Guangzhou

  • 015

    Hangzhou

  • 005

    Hefei

  • 008

    Heilongjiang

  • 011

    Jilin City

  • 022

    Jinan

  • 031

    Kunming

  • 028

    Nanjing

  • 009

    Shanghai

  • 018

    Shanghai

  • 020

    Shanghai

  • 030

    Shanghai

  • 038

    Shijiazhuang

  • 010

    Tianjin

  • 006

    Wuhan

  • 016

    Xi'an

  • 035

    Xi'an

Other trials in China

About this study

Official title: A Phase 3, Multicenter, Open-label Extension Study To Assess The Safety And Efficacy Of Certolizumab Pegol As Additional Medication To Methotrexate In Chinese Subjects With Active Rheumatoid Arthritis Who Participated In RA0044.

This study will continue to evaluate the safety \& efficacy of Certolizumab Pegol (CZP) for 6 months in Chinese subjects with active Rheumatoid Arthritis who participated in RA0044.

Read the detailed description

This study (RA0078) will continue to assess the safety, tolerability, and efficacy of Certolizumab Pegol (CZP) for 6 months as additional medication to methotrexate (MTX) with or without folic acid in Chinese subjects with active Rheumatoid Arthritis (RA) who participated in the main feeder study, RA0044. All subjects will continue to receive their established treatment with MTX with or without folic acid. The dose of MTX may be decreased by the Investigator due to toxicity, but should not be discontinued completely. Concomitant nonsteroidal anti-inflammatory drugs and oral corticosteroids will be permitted. For each subject, the study duration will last a maximum of approximately 32 weeks.

Being tested
Certolizumab Pegol
Keywords
Rheumatoid Arthritis, TNFα antagonist, Certolizumab pegol, Chinese patients, Open-label
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • Certolizumab PegolDrug

    Also called Cimzia

    Active Substance: Certolizumab Pegol Pharmaceutical form: Prefilled syringes Concentration: 200 mg/ ml Route of Administration: Subcutaneous injection

Study groups in NCT02319642
Study groupRoleWhat they receive
Certolizumab Pegol (CZP)Experimental1. Those subjects from either treatment group in RA0044 (NCT02151851) who fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14. These subjects are withdrawn from RA0044 (NCT02151851) at Week 16 of that study, and that assessment will also be the Entry assessment for this Extension study. In this OLE study, these subjects will receive CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W. 2. Subjects from either treatment group in RA0044 (NCT02151851) who completed RA0044 (NCT02151851) through Week 24. The Week 24 assessment in RA0044 (NCT02151851) will also be the Entry assessment for this Extension study. In this OLE study, these subjects will receive CZP 200 mg sc Q2W.
Receives: Drug: Certolizumab Pegol

What is being measured

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

  1. Percentage of Subjects That Withdrew Due to a Treatment-emergent Adverse Event (TEAE)

    TEAEs are defined as Advere Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.

    Measured: Baseline to the end of observation period (32 weeks)

  2. Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)

    TEAEs are defined as Adverse Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.

    Measured: Baseline to the end of observation period (32 weeks)

  3. Percentage of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE)

    Treatment emergent SAEs are defined as SAEs starting on or after the date of first study medication administration in this OLE study up to 70 days post-last dose.

    Measured: Baseline to the end of observation period (32 weeks)

Secondary outcomes (4)

  1. Percentage of Subjects Meeting the American College of Rheumatology 20 (ACR20) in Relation to Baseline

    The ACR20 represents improvement from Baseline of at least 20 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP).

    Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study drug administration in RA0044.

    Measured: Week 24

  2. Percentage of Subjects Meeting the American College of Rheumatology 50 (ACR50) in Relation to Baseline

    The ACR50 represents improvement from Baseline of at least 50 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP).

    Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044.

    Measured: Week 24

  3. Percentage of Subjects Meeting the American College of Rheumatology 70 (ACR70) in Relation to Baseline

    The ACR70 represents improvement from Baseline of at least 70 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP).

    Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044.

    Measured: Week 24

  4. Change From Baseline Value in Health Assessment Questionnaire-Disability Index (HAQ-DI)

    Each subject will complete the HAQ-DI questionnaire at the visit and provides an assessment of the impact of the disease and its treatment on physical function. HAQ-DI scores range from 0 to 3. Lower scores indicate less disability.

    Negative values indicate improvement from Baseline. Baseline refers to RA0044 baseline.

    Measured: Week 24

Timeline

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

  1. First posted18 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
347 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02319642
Sponsor's protocol ID
RA0078
Other IDs
CTR20140412
Acronym
RAPID-C OLE
Status last verified
Oct 2018
First submitted
15 Dec 2014
Last updated
16 Oct 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Certolizumab Pegol in people with Rheumatoid Arthritis, run by UCB Pharma SA at 30 sites in China.

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 9 inclusion and 26 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 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China. 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 16 Oct 2018). 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 That Withdrew Due to a Treatment-emergent Adverse Event (TEAE) (time frame: Baseline to the end of observation period (32 weeks)). The study lists 3 primary outcomes in all. 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 NCT02319642.

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 16 Oct 2018.

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