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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00993668
• Date of registration: 09/10/2009
• Primary sponsor: UCB, Inc.
• Public title: Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines
• Scientific 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
• Date of first enrolment: September 2009
• Target sample size: 224
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00993668
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Certolizumab pegol

Other: Placebo

Primary Outcome(s)

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)]

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(s)

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)]

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)]

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)]

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)]

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)]

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)]

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)]

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)]

Secondary ID(s)

RA0017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors