Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines
Condition: Rheumatoid Arthritis
MeSH terms: Influenza, Human; Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; Certolizumab pegol
Intervention description: 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 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).
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: influenza; vaccine; pneumococcal vaccine; certolizumab pegol; Cimzia

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.
    

Eligibility 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)