BackToBasic: Infliximab in Chronic Low Back Pain and Modic Changes

PHASE3CompletedINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

December 12, 2018

Primary Completion Date

July 27, 2023

Study Completion Date

September 29, 2023

Conditions
Low Back Pain
Interventions
DRUG

Biosimilar Infliximab

Intravenous infusion(5 mg/kg). Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98, unless unacceptable toxicity is encountered.

OTHER

Placebo

Intravenous infusion. Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98,

Trial Locations (6)

Unknown

Haukeland University Hospital, Bergen

Vestre Viken Hospital Trust Drammen, Drammen

Østfold Hospital Trust, Moss

University Hospital of North Norway, Tromsø

St. Olavs Hospital, Trondheim

0407

Oslo University Hospital Ullevål, Oslo

All Listed Sponsors
collaborator

Haukeland University Hospital

OTHER

collaborator

St. Olavs Hospital

OTHER

collaborator

University Hospital of North Norway

OTHER

collaborator

Vestre Viken Hospital Trust

OTHER

collaborator

Ostfold Hospital Trust

OTHER

collaborator

Clinical Trial Unit (CTU), Oslo University Hospital

UNKNOWN

collaborator

Diakonhjemmet Hospital

OTHER

lead

Oslo University Hospital

OTHER

NCT03704363 - BackToBasic: Infliximab in Chronic Low Back Pain and Modic Changes | Biotech Hunter | Biotech Hunter