A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab pegol
Intervention description: Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous Subjects will receive certolizumab pegol in a pre-specified sequence during the study.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Rheumatoid arthritis; Phase 1; Cimzia; Certolizumab pegol; Electrochemiluminescent immune-assay

Summary:

      The purpose of the study is to evaluate the pharmacokinetics and safety of certolizumab pegol
      in adults with active rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be 18 to 69 years of age inclusive, at the time of signing the
             informed consent

          -  Participant must have a diagnosis of moderately-to-severely active rheumatoid
             arthritis (RA)

          -  Participant must have had an inadequate response to, or intolerance to, at least 1
             disease modifying antirheumatic drug (DMARD) (nonbiologic or biologic)

          -  Participant has a negative interferon-gamma release assay (IGRA) at Screening

          -  Participant has a body mass index within the range 18.0 kg/m2 to 35.0 kg/m2
             (inclusive)

          -  Male or female

          -  A female participant is eligible to participate if:

             i) she is not pregnant, ii) not breastfeeding, iii) at least one of the following
             conditions applies:

               1. Not a woman of childbearing potential (WOCBP) OR

               2. A WOCBP who agrees to follow the contraceptive guidance during the Treatment
                  Period and until the Safety Follow-up (SFU) Visit

                  Exclusion Criteria:

          -  Participant has a known hypersensitivity to any components of the study
             medication(including polyethylene glycol) or comparative drugs (and/or an
             investigational device) as stated in this protocol

          -  Participant has clinically significant electrocardiogram (ECG) abnormalities at
             Screening

          -  Participant has previously been exposed to certolizumab pegol (CZP)

          -  Participant has failed treatment with ≥1 tumor necrosis factor (TNF) α inhibitor or
             was a primary failure for any TNFα antagonist. A primary failure is defined as no
             clinical disease improvement within the first 12 weeks of treatment (study
             participants who demonstrated clinical response within 12 weeks of treatment and
             subsequently lost response after 12 weeks of treatment are eligible)

          -  Participant has received a live vaccination within 6 weeks prior to Screening or
             intends to have a live vaccination during the course of the study or within 3 months
             following CZP treatment in the study

          -  Participant has received any investigational drug or experimental procedure within 90
             days prior to the first dose of IMPinvestigational medicinal product (IMP)

          -  Participant has a laboratory abnormality at Screening, including any of the following:

               1. >3.0x upper limit of normal (ULN) of any of the following: alanine
                  aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase
                  (ALP); or >ULN total bilirubin (>1.5x ULN total bilirubin if the participant has
                  a documented pre-study diagnosis of Gilbert's syndrome)

               2. white blood cell count <3.00x103/μL

               3. absolute neutrophil count (ANC) <1.5x103/μL

               4. lymphocyte count <500 cells/μL

               5. hemoglobin <8.5 g/dL

               6. Any other laboratory abnormality, which, in the opinion of the Investigator, will
                  prevent the study participant from completing the study or will interfere with
                  the interpretation of the study results