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Trial record 1 of 1 for:    ra0017
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Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00993668
Recruitment Status : Completed
First Posted : October 12, 2009
Results First Posted : June 20, 2011
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Placebo Biological: Certolizumab pegol Phase 4

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : September 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
 Other: Placebo
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).
Experimental: Cimzia
Certolizumab pegol
 Biological: Certolizumab pegol
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).
Other Name: Cimzia®


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 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. [ Time Frame: Baseline, End of single blind period (Week 6) ]

Secondary Outcome Measures :
  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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Baseline, End of single blind period (Week 6) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993668


Locations
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United States, Alabama
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Tuscaloosa, Alabama, United States
United States, Arizona
Peoria, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
United States, California
Los Angeles, California, United States
Palm Desert, California, United States
Santa Maria, California, United States
Santa Monica, California, United States
United States, Florida
Aventura, Florida, United States
Fort Lauderdale, Florida, United States
Melbourne, Florida, United States
Orange Park, Florida, United States
Palm Harbor, Florida, United States
Venice, Florida, United States
Vero Beach, Florida, United States
Zephyrhills, Florida, United States
United States, Idaho
Idaho Falls, Idaho, United States
Meridian, Idaho, United States
United States, Iowa
Cedar Rapids, Iowa, United States
United States, Michigan
Kalamazoo, Michigan, United States
Lansing, Michigan, United States
United States, Mississippi
Hattiesburg, Mississippi, United States
United States, Missouri
Florissant, Missouri, United States
United States, Nevada
Reno, Nevada, United States
United States, New York
Brooklyn, New York, United States
Smithtown, New York, United States
Syracuse, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
United States, Ohio
Middleburg Heights, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
Erie, Pennsylvania, United States
West Reading, Pennsylvania, United States
United States, South Carolina
Myrtle Beach, South Carolina, United States
Orangeburg, South Carolina, United States
United States, Texas
San Antonio, Texas, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Oak Creek, Wisconsin, United States
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1-877-822-9493 (UCB)
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00993668    
Other Study ID Numbers: RA0017
First Posted: October 12, 2009    Key Record Dates
Results First Posted: June 20, 2011
Last Update Posted: August 1, 2018
Last Verified: January 2012
Keywords provided by UCB Pharma:
influenza
vaccine
pneumococcal vaccine
certolizumab pegol
Cimzia
Additional relevant MeSH terms:
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Influenza, Human
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Certolizumab Pegol
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents