A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo of CDP870; CDP870 200mg; Methotrexate
Intervention description: Given every 2 weeks until Week22 (SC); 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week 22(SC); Received treatment with Methotrexate(MTX)for at least 24 weeks prior to the Baseline Visit.
The dose and route of administration of MTX had to have been stable for at least 8 weeks prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10mg weekly.
Intervention MeSH terms: Certolizumab Pegol; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: CDP870; Korea; CIMZIA

Summary:

      The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in
      combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in
      patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult-onset RA of at least 6 months but not longer than 15 years in duration as
             defined by the 1987 American College of Rheumatology classification criteria

          -  Active RA disease as defined by at least 9 tender joints and 9 swollen joints, ESR of
             30 mm/hour or CRP of 1.5 mg/dL

          -  MTX (with or without folic acid) for at least 24 weeks prior to the Baseline visit,
             The dose of MTX and route of administration must have been stable for at least 8 weeks
             prior to the baseline visit. The minimum stable dose of MTX allowed is 10 mg weekly.

        Exclusion Criteria:

          -  Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or
             reactive arthritis)

          -  Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)

          -  NYHA (New York Heart Association) Class III or IV congestive heart failure

          -  current or history of, tuberculosis

          -  history of chronic infection, recent serious or life-threatening infection (within 24
             weeks , including herpes zoster), or any current sign or symptom that may indicate an
             infection (e.g., fever, cough)

          -  High risk of infection

          -  Have received any experimental non-biological therapy, within or outside a clinical
             trial in the 12 weeks prior to Baseline

          -  Have received previous B-cell therapy (eg. Rituximab)

          -  Have received any other biological therapy for RA within 24 weeks prior to Baseline
             visit, except for etanercept where a three month washout prior to baseline visit is
             acceptable

          -  Have received previous treatment with a biological therapy for RA that resulted in a
             severe hypersensitivity reaction or an anaphylactic reaction

          -  Failed to respond to previous treatment with an anti-TNF drug

          -  Female breast feeding, pregnant or plan to become pregnant during the trial or for 12
             weeks following the last dose of study drug