ADALISKIAS: Adalimumab for Acute Disc Prolapse

NCT01510548 | Unknown Phase 3

• 1 other identifier: HUM53
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Disc prolapse; Pain; Disability

Outcome Measures

Primary Outcomes (1)

• Pain

  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.

  one year

Secondary Outcomes (2)

• need for operative treatment and functional status = proportion of patients operated after one year

  one year

• safety in general

  During one year follow up.

Study Arms (3)

Adalimumab 20 mg per week

ACTIVE COMPARATOR

Patient will get at double blind situation adalimumab 20 mg every week (six injections) injections

Biological: Adalimumab injections for acute disc prolapse patients

Adalimumab 40 mg per week

ACTIVE COMPARATOR

Patient will get at double blind situation adalimumab 40 mg per week injections

Biological: Adalimumab injections for acute disc prolapse patients

placebo arm

PLACEBO COMPARATOR

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

Interventions

Adalimumab injections for acute disc prolapse patients BIOLOGICAL

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.

Also known as: Biologic Drugs for ischias, Humira for ischias

Adalimumab 20 mg per week; Adalimumab 40 mg per week; placebo arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kuopio University Hospital: lead

Study Sites (1)

Kuopio University Hospital

Kuopio, 70210, Finland

Location

Related Publications (3)

• Cooper RG, Freemont AJ. TNF-alpha blockade for herniated intervertebral disc-induced sciatica: a way forward at last? Rheumatology (Oxford). 2004 Feb;43(2):119-21. doi: 10.1093/rheumatology/keh013. Epub 2003 Sep 16. No abstract available.

  PMID: 13130150 BACKGROUND

• Cuellar MJ, Montesano XP, Carstens E. Role of TNF-alpha in sensitization of nociceptive dorsal horn neurons induced by application of nucleus pulposus to L5 dorsal root ganglion in rats. Pain. 2004 Aug;110(3):578-587. doi: 10.1016/j.pain.2004.03.029.

  PMID: 15288398 BACKGROUND

• Genevay S, Stingelin S, Gabay C. Efficacy of etanercept in the treatment of acute, severe sciatica: a pilot study. Ann Rheum Dis. 2004 Sep;63(9):1120-3. doi: 10.1136/ard.2003.016451. Epub 2004 Apr 28.

  PMID: 15115710 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement; Pain

Interventions

Biological Products; Adalimumab

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complex Mixtures; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Olavi Airaksinen, MD

  MD, Head of Department of PRM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Ass Proff, Head of the Department of Rehabilitation

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 16, 2012
• Study Start: March 1, 2007
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 11, 2013

Record last verified: 2013-10

Locations

FI (1)