Open-label Study to Assess the Safety and Efficacy of CDP6038 (Olokizumab) in Patients Who Completed RA0056
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CDP6038 (olokizumab)
Intervention description: 100mg/ml solution for injection 120 mg subcutaneously (sc) every 2 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: RA0057 is a single arm study, however, analyses will also be performed according to the original treatment arms of the parent study RA0056 (NCT01242488).
Masking: None (Open Label)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid arthritis; CDP6038; Interleukin-6

Summary:

      The purpose of this study is to evaluate the long term safety and tolerability of CDP6038
      (olokizumab) treatment in adult subjects with active rheumatoid arthritis who completed study
      RA0056 (NCT01242488).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject completed the RA0056 study (Week 12 Visit)

          -  Subject must have maintained their stable dose (and route) of methotrexate (MTX)
             between 12.5 to 25mg/week in RA0056, and plan to maintain this same dose and route of
             administration for at least 12 weeks

          -  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 is not considered an
             acceptable method of contraception for this study

          -  Female subjects of childbearing potential must agree to use 2 methods of adequate
             contraception during the study and for 6 months (24 weeks) after their last CDP6038
             (olokizumab) dose

          -  Male subjects must agree to ensure that they or their female partner(s) use adequate
             contraception during the study and for 12 weeks after the subject receives their last
             dose of CDP6038 (olokizumab)

        Exclusion Criteria:

          -  Subject has an ongoing serious adverse event from the RA0056 study

          -  Female subject of childbearing potential has a positive pregnancy test at Week 12 in
             Study RA0056 or plans to become pregnant during the study or within 6 months (24
             weeks) following their last dose of study medication

          -  Subject has evidence of active or latent tuberculosis

          -  Subject is receiving any biologic response modifier or synthetic disease-modifying
             antirheumatic drug other than MTX

          -  Subject has an alcohol consumption of more than 1 unit per weekday. One unit equals 1
             glass of beer or lager (~330mL), a glass of wine (125mL), or a measure of spirits/hard
             liquor (25mL)

          -  Subject with any other condition in RA0056 (eg, clinically significant laboratory
             values, frequent adverse events) which in the Investigator's or Sponsor's judgment
             would make the subject unsuitable for inclusion in the study