Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multi-centre Double Blind Randomised Placebo-controlled Study of the Use of Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis
Brief Summary: Ulcerative Colitis (UC) is a life-long incurable disease with remissions and exacerbations. Inflammation confined to the rectum occurs in a quarter of patients and can be extremely hard to treat. Many medications have been tried in order to control the inflammation, but they do not always work. One of the newer medications is the immunosuppressing medication, tacrolimus that has been shown to be effective in UC when taken orally. Unfortunately, the oral use of this medication can have numerous serious side effects. In order to overcome these side effects, the use of topical rectal tacrolimus has been examined. Pilot studies in ulcerative proctitis (inflammation confined to the rectum) resistant to conventional therapies have demonstrated a clinical remission in 75% of patients and although the medication was well absorbed through the lining of the bowel, the levels in the blood were very low and no serious side effects were reported. The findings suggest that this preparation is indeed effective for inflammation in the distal bowel and that the method of administration reduces side effects. Further work, however, now needs to be undertaken to validate the original findings.


Options:
A: Arm Label: tofacitinib 10 mg BID; Type: EXPERIMENTAL; Interventions: Drug: tofacitinib | Arm Label: Placebo BID; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: tofacitinib; Assigned to Arm(s): tofacitinib 10 mg BID | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo BID
B: Arm Label: Induction Study - Placebo Intravenous (IV); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo IV | Arm Label: Induction Study - Ustekinumab 130 milligram (mg) IV; Type: EXPERIMENTAL; Interventions: Drug: Ustekinumab IV | Arm Label: Induction Study - Ustekinumab 6 mg/kg IV; Type: EXPERIMENTAL; Interventions: Drug: Ustekinumab IV | Arm Label: Induction Study- Placebo- Nonresponsders at Week 8; Type: OTHER; Interventions: Drug: Placebo SC, Drug: Ustekinumab IV | Arm Label: Induction study-Ustekinumab Nonresponders at Week 8; Type: OTHER; Interventions: Drug: Placebo IV, Drug: Ustekinumab SC | Arm Label: Maintenance Study - Placebo Subcutaneous (SC); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo SC | Arm Label: Maintenance Study - Ustekinumab 90mg SC every 12 weeks; Type: EXPERIMENTAL; Interventions: Drug: Ustekinumab SC | Arm Label: Maintenance Study - Ustekinumab 90mg SC every 8 weeks (q8w); Type: EXPERIMENTAL; Interventions: Drug: Ustekinumab SC | Arm Label: Maintenance Study - Placebo IV - Responder - Placebo SC; Type: OTHER; Interventions: Drug: Placebo SC | Arm Label: Maintenance Study-Delayed Responder-Ustekinumab 90mg SC q8w; Type: OTHER; Interventions: Drug: Ustekinumab SC | Intervention Type: DRUG; Name: Placebo IV; Assigned to Arm(s): Induction Study - Placebo Intravenous (IV), Induction study-Ustekinumab Nonresponders at Week 8 | Intervention Type: DRUG; Name: Placebo SC; Assigned to Arm(s): Induction Study- Placebo- Nonresponsders at Week 8, Maintenance Study - Placebo IV - Responder - Placebo SC, Maintenance Study - Placebo Subcutaneous (SC) | Intervention Type: DRUG; Name: Ustekinumab IV; Assigned to Arm(s): Induction Study - Ustekinumab 130 milligram (mg) IV, Induction Study - Ustekinumab 6 mg/kg IV, Induction Study- Placebo- Nonresponsders at Week 8 | Intervention Type: DRUG; Name: Ustekinumab SC; Assigned to Arm(s): Induction study-Ustekinumab Nonresponders at Week 8, Maintenance Study - Ustekinumab 90mg SC every 12 weeks, Maintenance Study - Ustekinumab 90mg SC every 8 weeks (q8w), Maintenance Study-Delayed Responder-Ustekinumab 90mg SC q8w
C: Arm Label: Rectal tacrolimus; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rectal tacrolimus | Arm Label: Rectal Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Rectal tacrolimus; Assigned to Arm(s): Rectal tacrolimus | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Rectal Placebo
D: Arm Label: tofacitinib 10 mg BID; Type: EXPERIMENTAL; Interventions: Drug: tofacitinib | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: tofacitinib; Assigned to Arm(s): tofacitinib 10 mg BID | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: C