{"groups":[{"description":"Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards.","id":"FG000","title":"Placebo"},{"description":"Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.","id":"FG001","title":"CZP 200 mg Q2W"},{"description":"Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during Safety Follow-Up Extension (SFE) Period. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).","id":"FG002","title":"SFE OL CZP 200 mg Q2W"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Study non-compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Patient's decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"As per suggestion"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Not eligible"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Missing/Unspecified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"158"},{"groupId":"FG001","numSubjects":"159"},{"groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"96"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"0"}],"type":"Received OL CZP"},{"achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"22"},{"groupId":"FG002","numSubjects":"0"}],"type":"Completed Week 52 Without Starting SFE"},{"achievements":[{"groupId":"FG000","numSubjects":"143"},{"groupId":"FG001","numSubjects":"142"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Double-Blind Period (Week 0 - 52)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"18"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Return to standard-of-care /OL CZP"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Patient's personal reason"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Investigator decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Subject withdrew consent due to traveling to site"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Compassionate access"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Patient travelling for study unable to continue"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Decision of Patient"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"comment":"123 subjects from Placebo arm and 120 subjects from CZP 200 mg Q2W arm","groupId":"FG002","numSubjects":"243"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"206"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"37"}],"type":"NOT COMPLETED"}],"title":"SFE Period (Week 52 - 156)"}],"preAssignmentDetails":"The Participant Flow refers to the Randomized Set (RS).","recruitmentDetails":"This study started to enroll participants in September 2015. The study included a Screening Period, up to 6 weeks before Baseline, a Double-Blind (DB) Period from Baseline (Week 0) to Week 52, that included the open label CZP (OL-CZP) treatment and other treatment (OT) and an Open Label Safety Follow-up Extension (SFE) Period, up to Week 156."}