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ADALISKIAS: Adalimumab for Acute Disc Prolapse

This study is currently recruiting participants.
Verified September 2012 by Kuopio University Hospital
Sponsor:
Information provided by (Responsible Party):
olavi airaksinen, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01510548
First received: January 2, 2012
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Disc Prolapse
Pain
 Biological: Adalimumab injections for acute disc prolapse patients
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adalimumab (Anti TNF Alfa) in the Management of Acute Lumbar Disc Prolapses - a One Year, Randomized, Placebo Controlled, Double Blind, Single Center Trial

Resource links provided by NLM:

MedlinePlus related topics: Sciatica
Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    As primary endpoint the functionality of the patients measured by Oswestry Disability Score and VAS (leg and back pain) will be evaluated and the proportion of patients in each group for the need of surgery at week 6 at the end of the study drug injections.


Secondary Outcome Measures:
  • need for operative treatment and functional status = proportion of patients operated after one year [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    As secondary endpoints functionality of the patient, need of operative treatment, sick leave days and pain killer consumption will be evaluated at week 1, 2, 4 and 6, 3 months, 6 months and 12 months 1 year after the start of study treatment.  

  • safety in general [ Time Frame: During one year follow up. ] [ Designated as safety issue: Yes ]

    All patients who receive study medication will be included to the safety analysis.

    Blood tests before and after administration will be analysed. Vital signs and clinical examination will be recorded on each visits All adverse and serious adverse events will be evaluated in connection to study medication during the follow-up time.



Estimated Enrollment: 90
Study Start Date: March 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Adalimumab 20 mg per week
Patient will get at double blind situation adalimumab 20 mg every week (six injections) injections
 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.
Other Names:
  • Biologic Drugs for ischias
  • Humira for ischias
Active Comparator: Adalimumab 40 mg per week
Patient will get at double blind situation adalimumab 40 mg per week injections
 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.
Other Names:
  • Biologic Drugs for ischias
  • Humira for ischias
Placebo Comparator: placebo arm
Patient will get at double blind situation placebo (= NaCl liquid solution, absolutely same color as the active drug) injections one per week during six weeks - same as the adalimumab arms
 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.
Other Names:
  • Biologic Drugs for ischias
  • Humira for ischias

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females over 18 years of age
  • Able and willing to give written informed consent
  • Acute or subacute (no more than 2 months) clinical sciatica symptoms caused by herniated disc prolapse confirmed by Magnetic Resonance Imaging (MRI).
  • Oswestry Disability Score at least 16% at entry.
  • VAS (leg and back pain) at least 40 mm at entry.
  • Able and willing to self-administer s.c. injections or have available a suitable person to administer s.c. injections.
  • A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment.

Exclusion criteria:

  • Prior treatment with any investigational agent within 30 days, or five half lives of the product whichever is longer.
  • Prior treatment with infliximab or etanercept.
  • History of chronic back pain.
  • Previously operated disc prolapse or other spinal column operation
  • Uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III-IV), recent stroke (within three months), chronic leg ulcer and any other condition (e.g. indwelling urinary catheter) which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
  • History of cancer or malignant lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
  • Positive serology for hepatitis B or C indicating active infection.
  • History of positive HIV status.
  • Persistent or recurrent infections or severe infections requiring hospitalization or treatment with i.v. antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
  • Previous diagnosis or signs highly indicative of central nervous system demyelinating diseases (e.g. optic neuritis, ataxia, apraxia).
  • History of active tuberculosis, histoplasmosis or listeriosis.
  • Female subjects who are pregnant or breast-feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510548

Contacts
Contact: Olavi Airaksinen, MD, PhD +35817173450 olavi.airaksinen@kuh.fi
Contact: jari arokoski, MD, PhD +35817173455 jari.arokoski@kuh.fi

Locations
Finland
Kuopio University Hospital Recruiting
Kuopio, Finland, 70210
Contact: Olavi Airaksinen, MD     +35817173450     olavi.airaksinen@kuh.fi    
Contact: Jari Arokoski, MD     +35817173455     jari.arokoski@kuh.fi    
Principal Investigator: Olavi Airaksinen, MD, PhD            
Sponsors and Collaborators
Kuopio University Hospital
Investigators
Principal Investigator: Olavi Airaksinen, MD MD, Head of Department of PRM
  More Information

Publications:

Responsible Party: olavi airaksinen, MD, PhD Ass Proff, Head of the Department of Rehabilitation, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01510548     History of Changes
Other Study ID Numbers: HUM53
Study First Received: January 2, 2012
Last Updated: September 26, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Kuopio University Hospital:
Disc prolapse
Pain
Disability

Additional relevant MeSH terms:
Intervertebral Disk Displacement
Prolapse
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
 Hernia
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013