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ADALISKIAS: Adalimumab for Acute Disc Prolapse

NCT01510548 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2013-10-11

No results posted yet for this study

Summary

Aims:

To study the efficacy and safety of adalimumab versus placebo in the treatment of acute disc prolapse will be will be compared up to 12 months after the start of study drug treatment.

Study type:

A one year,randomized, placebo controlled double blind single center trial.

Patients and study drug treatment:

The study population consist of 99 patients with sciatica caused by herniated disc prolapse.

The study has 3 arms: 33 patients randomized to adalimumab 40mg every week, 33 patients randomized to adalimumab 40mg every other week, and 33 patients randomized to placebo. Study drug treatment period will be six weeks.

Methods:

Clinical evaluation, global assessments and Oswestry Disability Score and visual analog scale (VAS) will be used as the evaluation of clinical results with the disc prolapse patients confirmed by Magnetic Resonance Imaging. Health related quality of life will be assessed by 15-D questionnaire. Safety will be evaluated by medical examinations, adverse events (AE) collection and laboratory measurements throughout the study period.

Conditions

  • Disc Prolapse
  • Pain

Interventions

BIOLOGICAL

Adalimumab injections for acute disc prolapse patients

see the study protocol. Three arms, which two of them included active medication and one will be placebo( NaCl solution) in controlled double blind setting.

Sponsors & Collaborators

  • Kuopio University Hospital

    lead OTHER

Principal Investigators

  • Olavi Airaksinen, MD · MD, Head of Department of PRM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01510548 on ClinicalTrials.gov