E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute or subacute (no more than 2 months) clinical sciatica caused by herniated disc prolapse |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036852 |
E.1.2 | Term | Prolapsed lumbar disc |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study the efficacy and safety of adalimumab vs placebo in the treatment of acute disc prolapse compared up to 12 months after the start of the study drug treatment. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-males and females over 18 years old -acute or subacute (no more than 2 months) clinical sciatica symptoms caused by herniated disc prolapse confirmed by MRI -Oswestry Disability Score at least 16% -VAS (leg and back pain) at least 40 mm -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 -able and willing to give written informed consent |
|
E.4 | Principal exclusion criteria |
-prior treatment with any investigational agent within 30 days, or 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 3-4), 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-metastic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of cervix -positive serology for hepatitis B or C indicating active infection -history of active tuberculosis, histoplasmosis or listeriosis -previous diagnosis or signs highly indicative of central nervous system demyelinating diseases (e.g. optic neuritis, ataxia, apraxia) -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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The functionality of the patients measured by Oswestry Disability Score and VAS (leg and back pain).
Secondary endpoints: Functionality of the patient, need of operative treatment, sick leave days and pain killer consumption. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |