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Rheumatoid ArthritisPhase 4NCT00993668

Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines

A Phase 4 study testing Certolizumab pegol in people with Rheumatoid Arthritis, run by UCB Pharma at 41 sites in United States.

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 purpose of this trial is to assess the affect of Certolizumab Pegol (CZP) treatment on antibody response to T cell-independent and T cell-dependent immunizations using pneumococcal and influenza vaccines, respectively. 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?
Yes, some participants may receive a placebo
How many people
224 participants
Where
41 sitesUnited States
Study dates
Sep 2009to Feb 2011
Phase
Phase 4
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

  • Subjects must be at least 18 years old at the screening visit
  • Subjects must be able to understand the information provided to them and to give written informed consent, and be able and willing to comply with the study requirements
  • Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier and spermicide. Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for 10 weeks after the last dose of CZP. Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for 10 weeks after the subject receives their last dose of CZP
  • Subjects must have a diagnosis of adult-onset Rheumatoid Arthritis (RA) of at least 6-months duration as defined by the 1987 American College of Rheumatology (ACR) classification criteria
  • Subjects must have active RA disease as defined by: ≥ 4 tender joints (28 joint count) at Screening and Week 0; and ≥ 4 swollen joints (28 joint count) at Screening and Week 0

Who cannot join

  • Subjects who have a diagnosis of any other inflammatory arthritis (eg., psoriatic arthritis or ankylosing spondylitis)
  • Subjects who have a history of an infected joint prosthesis at any time with that prosthesis still in situ
  • Subjects must be free of defined prohibited medication and biological therapy
  • Subjects who have received any experimental nonbiological therapy, within or outside of a clinical trial in the 3 months prior to Week 0
  • Subjects who have received any experimental biological agent in the past 3 months or within 5 half-lives prior to Week 0 (whichever is longer)
  • Subjects who have received previous treatment with biological response modifier therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction.
Show all 27Show fewer
  • Subjects with a history of pneumococcal or influenza infection in the last 3 months
  • Subjects with a history of pneumococcal vaccination in the last 5 years
  • Subjects with a history of influenza vaccination within the last 6 months
  • Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the trial or within 3 months following last dose of study drug
  • Subjects with a history of chronic or recurrent infections (more than 3 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life-threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection
  • Subjects who have had a splenectomy
  • Subjects who have had a hypersensitivity reaction to previous pneumococcal or influenza vaccination
  • Subjects who have a known hypersensitivity to eggs and egg products or to other components of the vaccine
  • Subjects with a history of Guillain-Barre syndrome
  • Subjects with a history of tuberculosis, active tuberculosis, positive chest x-ray for tuberculosis, or positive purified protein derivative (PPD) skin test (defined as induration of ≥5 mm). Subjects who are not candidates for PPD testing due to prior severe reaction to the PPD test or a history of PPD positivity must undergo an Elispot test instead for tuberculosis evaluation. Subjects testing positive via the PPD or having an indeterminate or positive Elispot test, or for which latent tuberculosis cannot be ruled out, may be enrolled in the study provided that they are treated (eg., isoniazid for 9 months) and that their treatment has been initiated at least 4 weeks prior to the first administration of CZP
  • Subjects at high risk of infection (eg., presence of leg ulcers or an indwelling urinary catheter, persistent or recurrent chest infections, bedridden or wheelchair bound subjects)
  • Subjects with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease
  • Subjects with known concurrent acute or chronic viral hepatitis B or C or positive hepatitis B surface antigen (HBs-Ag) or hepatitis C virus antibody (HCV-Ab)
  • Subjects with known human immunodeficiency virus (HIV) infection
  • Subjects receiving any live or attenuated vaccination within 12 weeks prior to Week 0
  • Concurrent malignancy or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than 5 years prior to screening)
  • Subjects with Class III or Class IV congestive heart failure according to the New York Heart Association (NYHA) 1964 classification criteria
  • Subjects with a history of, or suspected, demyelinating disease of the central nervous system (eg., multiple sclerosis or optic neuritis)
  • Subjects with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
  • Subjects with any other condition (eg., clinically significant laboratory values) which in the Investigator's judgement would make the subject unsuitable for inclusion in the study
  • Subjects with a history of an adverse reaction to polyethylene glycol (PEG)

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Study site

    Asheville, North Carolina

  • Study site

    Aventura, Florida

  • Study site

    Birmingham, Alabama

  • Study site

    Brooklyn, New York

  • Study site

    Cedar Rapids, Iowa

  • Study site

    Charlotte, North Carolina

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Erie, Pennsylvania

  • Study site

    Florissant, Missouri

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Hattiesburg, Mississippi

  • Study site

    Huntsville, Alabama

  • Study site

    Idaho Falls, Idaho

  • Study site

    Kalamazoo, Michigan

  • Study site

    Lansing, Michigan

  • Study site

    Los Angeles, California

  • Study site

    Melbourne, Florida

  • Study site

    Meridian, Idaho

  • Study site

    Middleburg Heights, Ohio

  • Study site

    Myrtle Beach, South Carolina

  • Study site

    Oak Creek, Wisconsin

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange Park, Florida

  • Study site

    Orangeburg, South Carolina

  • Study site

    Palm Desert, California

  • Study site

    Palm Harbor, Florida

  • Study site

    Peoria, Arizona

  • Study site

    Reno, Nevada

  • Study site

    San Antonio, Texas

  • Study site

    Santa Maria, California

  • Study site

    Santa Monica, California

  • Study site

    Scottsdale, Arizona

  • Study site

    Seattle, Washington

  • Study site

    Smithtown, New York

  • Study site

    Syracuse, New York

  • Study site

    Tucson, Arizona

  • Study site

    Tuscaloosa, Alabama

  • Study site

    Venice, Florida

  • Study site

    Vero Beach, Florida

  • Study site

    West Reading, Pennsylvania

  • Study site

    Zephyrhills, Florida

Other trials in United States

About this study

Official title: A Phase 4, Randomized, Single-blind, Placebo-controlled, Multicenter Study to Evaluate the Immunogenicity of Pneumococcal and Influenza Vaccines in Adult Subjects With Rheumatoid Arthritis Receiving Certolizumab Pegol or Placebo

The purpose of this trial is to assess the affect of Certolizumab Pegol (CZP) treatment on antibody response to T cell-independent and T cell-dependent immunizations using pneumococcal and influenza vaccines, respectively.

Being tested
Placebo, Certolizumab pegol
Keywords
influenza, vaccine, pneumococcal vaccine, certolizumab pegol, Cimzia
Medical subject headings
Arthritis, Rheumatoid, Influenza, Human

What participants receive

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

  • PlaceboOther

    Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).

  • Certolizumab pegolBiological

    Also called Cimzia®

    Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).

Study groups in NCT00993668
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Other: Placebo
CimziaExperimentalCertolizumab pegol
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 Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.

    Measured: Baseline, End of single blind period (Week 6)

  2. Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.

    Measured: Baseline, End of single blind period (Week 6)

Secondary outcomes (8)

  1. Percentage of All Subjects Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.

    Measured: End of single blind period (Week 6)

  2. Percentage of All Subjects Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.

    Measured: End of single blind period (Week 6)

  3. Percentage of Subjects With no Previous Protective Pneumococcal Antibody Titers at Baseline With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.

    Measured: Baseline, End of single blind period (Week 6)

  4. Percentage of Subjects With no Previous Protective Influenza Antibody Titers at Baseline With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.

    Measured: Baseline, End of single blind period (week 6)

  5. Percentage of All Subjects With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.

    Measured: End of single blind period (Week 6)

  6. Percentage of All Subjects With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.

    Measured: End of single blind period (Week 6)

  7. Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens at Week 6 by Concomitant Methotrexate (MTX) Use.

    Measured: Baseline, End of single blind period (Week 6)

  8. Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens at Week 6 by Concomitant MTX Use.

    Measured: Baseline, End of single blind period (Week 6)

Timeline

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

  1. First posted12 Oct 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJun 2010
  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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00993668
Sponsor's protocol ID
RA0017
Status last verified
Jan 2012
First submitted
9 Oct 2009
Last updated
1 Aug 2018
Data monitoring committee
No
Expanded access
Available

Publications

  • Kivitz AJ, Schechtman J, Texter M, Fichtner A, de Longueville M, Chartash EK. Vaccine responses in patients with rheumatoid arthritis treated with certolizumab pegol: results from a single-blind randomized phase IV trial. J Rheumatol. 2014 Apr;41(4):648-57. doi: 10.3899/jrheum.130945. Epub 2014 Mar 1.

    PubMed 24584918

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Certolizumab pegol in people with Rheumatoid Arthritis, run by UCB Pharma at 41 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 5 inclusion and 27 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 41 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 20 Jun 2011). 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 Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6. (time frame: Baseline, End of single blind period (Week 6)). 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 NCT00993668, 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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