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Rheumatoid ArthritisPhase 3NCT00160693

Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis

A Phase 3 study testing Certolizumab Pegol in people with Rheumatoid Arthritis, run by UCB Pharma at 61 sites in 7 countries.

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

The primary purpose of this study is to obtain long-term safety data with CZP in patients with Rheumatoid Arthritis (RA). Additional objectives are to assess the dose and type of Arthritis medication(s) utilized by patients, and to assess the long-term impact of CZP on physical function. 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
402 participants
Where
61 sitesin 7 countries
Study dates
Mar 2003to Feb 2011
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

  • Participation in CZP trial C87014 or C87011
  • If female and of childbearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception since her last menses, will use adequate contraception during the study and for 12 weeks after the last dose of study drug (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the day of receiving the first dose of study drug
  • Must have provided written informed consent before undergoing any study procedures

Who cannot join

  • History (Hx) of chronic infection, serious or life-threatening infection - (including Herpes Zoster) within 6 months prior, or any current symptom indicating infection
  • Current or recent Hx of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
  • Any finding indicative of Tuberculosis at end of previous study
  • Known HIV infection
  • Persistently abnormal AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) results (> 2 times upper limit of normal)
  • Hemoglobin (Hgb) levels < 9 g/dL or Hematocrit < 30 %
Show all 12Show fewer
  • Total White Blood Cell (WBC) count of < 3.0 x 100/L (< 3000/mm^3)
  • Platelet count < 100 x 100 L (100,000/mm^3)
  • Serum creatinine > 1.5 times upper limit of normal based on patient age and sex
  • Receipt of any biological therapies for RA in 6 months prior to study entry or any prior treatment (tx) with Tumor Necrosis Factor (TNF) blocking agent (excluding CDP870)
  • Receipt of any vaccination (live, attenuated or killed) in 8 weeks prior to Baseline
  • Any other condition which the Principal Investigator judges would make patient unsuitable for study participation

Trial locations and contacts

61 sites in 7 countries.

61 sites in 7 countries

United States29 sites

  • Study site

    Austin, Texas

  • Study site

    Aventura, Florida

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Coeur d'Alene, Idaho

  • Study site

    Dallas, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Duncanville, Texas

  • Study site

    Erie, Pennsylvania

  • Study site

    Everett, Washington

  • Study site

    Fall River, Massachusetts

  • Study site

    Huntsville, Alabama

  • Study site

    Lincoln, Nebraska

  • Study site

    Lubbock, Texas

  • Study site

    Memphis, Tennessee

  • Study site

    Ocala, Florida

  • Study site

    Orlando, Florida

  • Study site

    Paradise Valley, Arizona

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, Texas

  • Study site

    Springfield, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Reading, Pennsylvania

  • Study site

    Wheaton, Maryland

  • Study site

    Wichita, Kansas

Other trials in United States

United Kingdom10 sites

  • Study site

    Birmingham

  • Study site

    Cannock

  • Study site

    Colchester

  • Study site

    Glasgow

  • Study site

    Harrogate

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Metropolitan Borough of Wirral

  • Study site

    Oxford

  • Study site

    Peterborough

Other trials in United Kingdom

Germany7 sites

  • Study site

    Berlin

  • Study site

    Cologne

  • Study site

    Gortlitz

  • Study site

    Hamburg

  • Study site

    Jena

  • Study site

    Leipzig

  • Study site

    Ratingen

Other trials in Germany

Czechia6 sites

  • Study site

    České Budějovice

  • Study site

    Liberec

  • Study site

    Ostrava Trebovice

  • Study site

    Prague

  • Study site

    Praha4 -KRC

  • Study site

    Uherské Hradiště

Other trials in Czechia

Belgium4 sites

  • Study site

    Antwerp

  • Study site

    Diepenbeek

  • Study site

    Liège

  • Study site

    Merksem

Other trials in Belgium

Austria3 sites

  • Study site

    Graz

  • Study site

    Klagenfurt

  • Study site

    Vienna

Other trials in Austria

Ireland2 sites

  • Study site

    Dublin

  • Study site

    Waterford

Other trials in Ireland

About this study

Official title: A Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid Arthritis

The primary purpose of this study is to obtain long-term safety data with CZP in patients with Rheumatoid Arthritis (RA). Additional objectives are to assess the dose and type of Arthritis medication(s) utilized by patients, and to assess the long-term impact of CZP on physical function. Treatment will continue up to approval of a marketing application for this product.

Being tested
Certolizumab Pegol
Keywords
Rheumatoid Arthritis, America College of Rheumatology, Disease modifying anti-rheumatic drug, Certolizumab Pegol (CDP870)
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 PegolBiological

    Also called Cimzia

    400 mg of Certolizumab Pegol subcutaneously every 4 Weeks

Study groups in NCT00160693
Study groupRoleWhat they receive
Certolizumab PegolExperimentalNot described
Receives: Biological: Certolizumab Pegol

What is being measured

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

  1. Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years

    An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

    First dose of CZP was at Baseline of one of the feeder studies C87011 [NCT00548834] or C87014 [NCT00544154] for subjects randomized to CZP, or at First Visit (Week 0) of this study for subjects randomized to Placebo.

    Measured: From first dose of CZP up to 8 years

  2. Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years

    An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

    The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.

    Measured: From First Visit (Week 0 in this study) up to 8 years

Secondary outcomes (12)

  1. Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52

    The assessments are based on a 20% or greater improvement from Baseline to Week 52 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Baseline is Baseline of the respective feeder study.

    Measured: From Baseline to Week 52

  2. Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100

    The assessments are based on a 20% or greater improvement from Baseline to Week 100 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Baseline is Baseline of the respective feeder study.

    Measured: From Baseline to Week 100

  3. Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160

    The assessments are based on a 20% or greater improvement from Baseline to Week 160 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Baseline is Baseline of the respective feeder study.

    Measured: From Baseline to Week 160

  4. Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208

    The assessments are based on a 20% or greater improvement from Baseline to Week 208 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Baseline is Baseline of the respective feeder study.

    Measured: From Baseline to Week 208

  5. Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256

    The assessments are based on a 20% or greater improvement from Baseline to Week 256 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Baseline is Baseline of the respective feeder study.

    Measured: From Baseline to Week 256

  6. Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316

    The assessments are based on a 20% or greater improvement from Baseline to Week 316 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Baseline is Baseline of the respective feeder study.

    Measured: From Baseline to Week 316

  7. Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit

    The assessments are based on a 20% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Measured: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years

  8. Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit

    The assessments are based on a 50% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 50% or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Measured: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years

  9. Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit

    The assessments are based on a 70% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 70% or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

    Measured: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years

  10. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit

    The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.

    Measured: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years

  11. Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years

    Measured: From First Visit (Week 0 in this study) up to 8 years

  12. Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years

    This Secondary Outcome Measure shows additional arthritis medications received by at least 20% of subjects during the 8-year study.

    Measured: From First Visit (Week 0 in this study) up to 8 years

Timeline

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

  1. First posted12 Sep 2005 (estimated)
  2. Study startMar 2003
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

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
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00160693
Sponsor's protocol ID
C87015
Other IDs
2005-002617-21, 2005
Status last verified
Mar 2018
First submitted
6 Sep 2005
Last updated
1 Aug 2018
Data monitoring committee
No
Expanded access
Available

Publications

  • Fleischmann R, van Vollenhoven RF, Vencovsky J, Alten R, Davies O, Mountian I, de Longueville M, Carter D, Choy E. Long-Term Maintenance of Certolizumab Pegol Safety and Efficacy, in Combination with Methotrexate and as Monotherapy, in Rheumatoid Arthritis Patients. Rheumatol Ther. 2017 Jun;4(1):57-69. doi: 10.1007/s40744-017-0060-8. Epub 2017 Mar 28.

    PubMed 28353191

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 at 61 sites in 7 countries.

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 3 inclusion and 12 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 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, United Kingdom, Germany, Czechia, Belgium and 2 more countries. 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 9 Jul 2012). 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 With at Least One Adverse Event (AE) During the Study Period of 8 Years (time frame: From first dose of CZP up to 8 years). The study lists 2 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 NCT00160693, 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 1 Aug 2018.

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