Table 3.

Permitted previous and concomitant therapies in clinical trials of advanced therapies for the treatment of ulcerative colitis.

Clinical trial	Prohibited concomitant therapies	Permitted concomitant therapies [minimum duration of previous treatment]	Tapering of concomitant corticosteroids
Infliximab
ACT 1 and ACT 2 [induction and maintenance]	• Rectally administered corticosteroids or rectal 5-ASA [2 weeks]	• Corticosteroids [minimum not stated] • Thiopurines [minimum not stated] • 5-ASA [minimum not stated; ACT 2 only]	Mandatory attempt; after Week 8: 5 mg/week until a dose of 20 mg/day; thereafter, 2.5 mg/week until discontinuation
Adalimumab
ULTRA 1 [induction], ULTRA 2 [induction and maintenance]	• Intravenously administered corticosteroids [2 weeks] • Cyclosporine, tacrolimus, mycophenolate mofetil, or methotrexate [30 days] • Therapeutic enema or suppository [14 days] • Investigational drugs [30 days or five half-lives]	• Corticosteroids ≥20 mg/day [14 days] • Corticosteroids <20 mg/day [40 days] • Azathioprine ≥1.5 mg/kg/day or 6-mercaptopurine ≥1 mg/kg/day [90 days; stable for 28 days] • 5-ASA [stable dose; minimum not stated]	Not mandatory; after Week 8: at the discretion of the investigator
Golimumab
PURSUIT-SC [induction], PURSUIT-M [maintenance]	• Anti-TNF, B-, or T-cell-depleting agents [12 months] • Cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil [8 weeks] • Investigational drugs [five half-lives]	• Corticosteroids ≤40 mg/day [stable for 2 weeks] • Thiopurines [stable for 4 weeks] • 5-ASA [stable for 2 weeks]	Mandatory attempt; from Week 1 of maintenance: 5 mg/week [for doses >20 mg/day] or 2.5 mg/week [for doses ≤20 mg/day]
Vedolizumab
GEMINI 1 [induction], GEMINI 1 [maintenance]	• Anti-TNF [60 days] • Cyclosporine, thalidomide, or investigational drugs [30 days]	• Corticosteroids ≤30 mg/day [stable for 4 weeks; 2 weeks if being tapered] • Thiopurines [stable for 8 weeks] • 5-ASA [stable for 2 weeks] • Probiotics [stable for 2 weeks] • Anti-diarrhoeals [no minimum]	Mandatory attempt if clinical response achieved; from Week 6 or as soon as clinical response achieved: 5 mg/week [for doses >10 mg/day] or 2.5 mg/week [for doses ≤10 mg/day]; dose could be increased to the original dose with tapering to resume within 2 weeks
Tofacitinib
OCTAVE Induction 1 & 2 [induction], OCTAVE Sustain [maintenance]	• Thiopurines or methotrexate [2 weeks] • Anti-TNF or interferon therapy [8 weeks] • Intravenously administered corticosteroids or rectally administered corticosteroids or 5-ASA [2 weeks] • Anti-adhesion molecule therapy, lymphocyte depleting agents, other immunosuppressants, or immunomodulatory biologics [1 year]	• Oral glucocorticoids ≤25 mg/day [stable throughout induction] • 5-ASA [stable throughout induction]	Mandatory attempt from Week 1 of maintenance: 5 mg/week [for doses >20 mg/day] or 2.5–5 mg/week [for doses 11–20 mg/day] or 2.5 mg/week [for doses ≤10 mg/day]; dose could be increased once during the study to the previous dose with tapering subsequently resumed to achieve steroid-free status. Inability to complete taper was counted as treatment failure per protocol
Ozanimod
TOUCHSTONE [induction and maintenance]	• Immunomodulatory biologics [4 months] • Biologic agent or investigational drug [five half-lives] • Rectally administered steroids [2 weeks] • Live vaccine [4 weeks]	• Corticosteroids ≤20 mg/day [4 weeks, stable for 2 weeks] • 5-ASA [6 weeks, stable for 3 weeks]	Not mandatory; after Week 8: at the discretion of the investigator

Corticosteroid doses given are for prednisone or equivalent dose of other corticosteroid.

5-ASA, 5-aminosalicylates; TNF, tumour necrosis factor.