Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; Certolizumab Pegol (CZP) 200 mg; Certolizumab Pegol (CZP) 400 mg
Intervention description: Placebo provided for the first subcutaneous injection in single-use vials at Week 0 (2 vials required), then Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4 and 6, followed by Certolizumab Pegol (CZP) 200 mg every 2 weeks from Week 8 to Week 40; Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40; Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cimzia®; CDP870; CZP; Certolizumab Pegol; Rheumatoid Arthritis; MRI

Summary:

      Phase IIIb study to determine early response to Certolizumab Pegol (CZP) with Magnetic
      Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials
      (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a diagnosis of adult-onset Rheumatoid Arthritis (RA) of at least 3
             months duration but no longer than 15 years

          -  Subjects with an active adult Rheumatoid Arthritis disease

          -  Subjects who have been on Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy for at
             least 12 weeks

        Exclusion Criteria:

          -  Subject must not have a secondary, non-inflammatory type of musculoskeletal condition
             (eg, osteoarthritis or fibromyalgia) that in the investigator's opinion is symptomatic
             enough to interfere with evaluation of the effect of study drug on the subject's
             primary diagnosis of Rheumatoid Arthritis (RA)

          -  Subject must not have a diagnosis of any other inflammatory arthritis (eg, psoriatic
             arthritis or ankylosing spondylitis)

          -  Subject must not have a history of an infected joint prosthesis at any time with
             prosthesis still in situ

          -  Subject must not have received more than 1 biological agent

          -  Subject must not have a history of lymphoproliferative disorder including lymphoma or
             signs and symptoms suggestive of lymphoproliferative disease at any time

          -  Subject with known Tuberculosis (TB) disease, high risk of acquiring TB infection or
             latent TB infection

          -  Subject must not have a known hypersensitivity to any components of the
             investigational medicinal product

          -  Subject must not have contraindications for Magnetic Resonance Image (MRI) and
             contrast agent

          -  Subject must not have any other condition which, in the investigator's judgement,
             would make them unsuitable for inclusion in the study