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

NCT00993668 | Completed Phase 4 Results

• 1 other identifier: RA0017
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 41

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

influenza; vaccine; pneumococcal vaccine; certolizumab pegol; Cimzia

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, End of single blind period (Week 6)

• 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.

  Baseline, End of single blind period (Week 6)

Secondary Outcomes (8)

• 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.

  End of single blind period (Week 6)

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

  End of single blind period (Week 6)

• 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.

  Baseline, End of single blind period (Week 6)

• 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.

  Baseline, End of single blind period (week 6)

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

  End of single blind period (Week 6)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Cimzia

EXPERIMENTAL

Certolizumab pegol

Biological: Certolizumab pegol

Interventions

Placebo OTHER

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).

Placebo

Certolizumab pegol BIOLOGICAL

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).

Also known as: Cimzia®

Cimzia

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (41)

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Tuscaloosa, Alabama, United States

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Peoria, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Los Angeles, California, United States

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Palm Desert, California, United States

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Santa Maria, California, United States

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Santa Monica, California, United States

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Aventura, Florida, United States

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Fort Lauderdale, Florida, United States

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Melbourne, Florida, United States

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Orange Park, Florida, United States

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Palm Harbor, Florida, United States

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Venice, Florida, United States

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Vero Beach, Florida, United States

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Zephyrhills, Florida, United States

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Idaho Falls, Idaho, United States

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Meridian, Idaho, United States

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Cedar Rapids, Iowa, United States

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Kalamazoo, Michigan, United States

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Lansing, Michigan, United States

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Hattiesburg, Mississippi, United States

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Florissant, Missouri, United States

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Reno, Nevada, United States

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Brooklyn, New York, United States

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Smithtown, New York, United States

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Syracuse, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Middleburg Heights, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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Erie, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Myrtle Beach, South Carolina, United States

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Orangeburg, South Carolina, United States

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San Antonio, Texas, United States

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Seattle, Washington, United States

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Oak Creek, Wisconsin, United States

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Related Publications (1)

• 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.

  PMID: 24584918 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Arthritis, Rheumatoid; Influenza, Human

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract 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 Clinical Trial Call Center
• Organization: UCB, Inc

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1-877-822-9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 9, 2009
• First Posted: October 12, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: February 1, 2011
• Last Updated: August 1, 2018
• Results First Posted: June 20, 2011

Record last verified: 2012-01

Locations

US (41)