After Version 3.0 is approved, patients may continue on the active medications of their induction regimen and be followed every 4 weeks per the Version 3.0 induction therapy schedule. Patients on Version 3.0 who meet certain criteria for treatment interruption proceed to Step 3. Patients who entered the study prior to Version 3.0 and choose not to undergo treatment interruption or patients who are ineligible for treatment interruption continue on study medications through Week 112. Patients are followed off therapy for 24 weeks or through Week 112, whichever is later. Patients who meet certain criteria for reinduction therapy proceed to Step 4.
Treatment is restarted for patients who meet certain criteria.
Patients who meet certain criteria for second treatment interruption proceed to Step 5. Patients who are ineligible for a second treatment interruption continue on reinduction therapy for 24 weeks or through Week 112, whichever is later. Treatment is interrupted as in Step 3. Patients who meet the criteria to restart therapy prior to Week 112 proceed to Step 6. Patients receive treatment as in Step 4.