Tocilizumab for Painful Chronic Pancreatitis: A Randomised, Placebo-controlled, Double-blinded, Investigator-initiated Trial (TOPAC trial)

Conditions

Chronic pancreatitis

Brief summary

The primary outcome assessment parameter is the total score of the COMPAT-SF questionnaire (31). The primary endpoint is the difference between the tocilizumab and placebo-treated groups in the COMPAT-SF score after 24 weeks.

Detailed description

The European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-C30) questionnaire between treatment groups (tocilizumab vs. placebo) at weeks 12 and 24., The Brief Pain Inventory Short Form (mBPI-SF) pain severity and interference scores between treatment groups (tocilizumab vs. placebo) at weeks 12 and 24., The average daily pain score (registered in the mBPI-SF) between treatment groups (tocilizumab vs. placebo) at week 24., The Patient Global Impression of Change (PGIC) questionnaire between treatment groups (tocilizumab vs. placebo) at week 24., The CP prognosis score (COPPS)-score between treatment groups (tocilizumab vs. placebo) at week 24., Use of analgesics, including opioid-based therapies (type and dose)., Adherence to treatment and frequency of adverse events.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGNatriumklorid ”B. Braun”

DRUGRoActemra 20 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary outcome assessment parameter is the total score of the COMPAT-SF questionnaire (31). The primary endpoint is the difference between the tocilizumab and placebo-treated groups in the COMPAT-SF score after 24 weeks.	—

Secondary

Measure	Time frame
The European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-C30) questionnaire between treatment groups (tocilizumab vs. placebo) at weeks 12 and 24., The Brief Pain Inventory Short Form (mBPI-SF) pain severity and interference scores between treatment groups (tocilizumab vs. placebo) at weeks 12 and 24., The average daily pain score (registered in the mBPI-SF) between treatment groups (tocilizumab vs. placebo) at week 24., The Patient Global Impression of Change (PGIC) questionnaire between treatment groups (tocilizumab vs. placebo) at week 24., The CP prognosis score (COPPS)-score between treatment groups (tocilizumab vs. placebo) at week 24., Use of analgesics, including opioid-based therapies (type and dose)., Adherence to treatment and frequency of adverse events.	—

Measure

Time frame

The European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-C30) questionnaire between treatment groups (tocilizumab vs. placebo) at weeks 12 and 24., The Brief Pain Inventory Short Form (mBPI-SF) pain severity and interference scores between treatment groups (tocilizumab vs. placebo) at weeks 12 and 24., The average daily pain score (registered in the mBPI-SF) between treatment groups (tocilizumab vs. placebo) at week 24., The Patient Global Impression of Change (PGIC) questionnaire between treatment groups (tocilizumab vs. placebo) at week 24., The CP prognosis score (COPPS)-score between treatment groups (tocilizumab vs. placebo) at week 24., Use of analgesics, including opioid-based therapies (type and dose)., Adherence to treatment and frequency of adverse events.

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Countries

Denmark

Outcome results

None listed