| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | To determine the efficacy of adalimumab in disc herniation-induced sciatica in a controlled randomised double blind pilot study. | |
| 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 | 10039674 | | E.1.2 | Term | Sciatica | |
| 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 | The primary outcome will be: success or failure of the treatment at 1 week. The patient will perceived the overall degree of improvement or deterioration on a descriptive four
item scale (recovery, marked improvement, slight improvement, or worse). The patient rating recovery or marked improvement will be considered as a success; and rating slight improvement or worse will considered as a failure.
| |
| E.2.2 | Secondary objectives of the trial | | Secondary outcomes : VAS, Oswestry questionnaire | |
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria | 1. Age > 18 year and < 70 year
2. first episode of unilateral sciatica or recurrence lasting for a minimum of 15 days and a maximum of 90 days.
3. Sciatica defined as :
- Presence of intermittent (for at least 8 hours) or constant unilateral pain radiating below the knee
- Signs of nerve root irritation: a positive-straight leg test or nerve root compression (motor, sensory or reflex deficits).
- Evidence of herniated nucleus pulposus on lumbar spine CT or MRI at the level corresponding to the symptoms and clinical findings.
4. VAS leg > 30 mm
5. Oswestry Score > 20
6. If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion:
·condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) contraceptives (oral or parenteral) for 3 months prior to study drug administration)
·a vasectomized partner
7. Subject must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
8. Subject must be able and willing to self-administer SC injections or has available qualified person(s) to administer SC injections. | |
| E.4 | Principal exclusion criteria | 1.Symptoms of cauda equida syndrome
2.CT or MRI showed evidence of nerve root compression from causes other than a herniated nucleus pulposus
3.patient had received a corticosteroids epidural for the current episode in the preceding 90 days
4.allergy to local anaesthetics
5.previous low back surgery
6.work accident, out of work for more than one year
7.Medical history of tuberculosis. Positive PPD/intradermal reaction or an abnormal chest x-ray suggestive of active TB.
8.History of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
9.Immuno-compromised conditions or history of HIV.
10.History of listeriosis, history of histoplasmosis, active TB, persistent chronic or active infections requiring treatment with intravenous (iv) antibiotics, iv antivirals, or iv antifungals within 30 days or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to study entry
11.History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
12.Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study. There should be at least a 150-day period between the last dose of study drug and either conception or initiation of breast-feeding in women of childbearing potential.
13.Poorly controlled medical condition, such as uncontrolled diabetes with documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
14.Investigational biological and chemical agents within 5 half-lives prior to Screening visit or within a longer or shorter time period depending on the mechanism of action.
15.History of clinically significant drug or alcohol abuse
16.The investigator considers the subject, for any reason, to be unacceptable for study participation.
17.Patient who has a known blood coagulation disorder
18.Medical history of demyelinating disease
19.Medical history of systemic lupus erythematosus
20.Presence of acute or chronic Hepatitis B or a history of Hepatitis C.
| |
| E.5 End points |
| E.5.1 | Primary end point(s) | The primary outcome will be: success or failure of the treatment at 1 week. The patient will perceived the overall degree of improvement or deterioration on a descriptive four
item scale (recovery, marked improvement, slight improvement, or worse). The patient rating recovery or marked improvement will be considered as a success; and rating slight improvement or worse will considered as a failure.
| |
| 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 | Yes |
| 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 | Information not present in EudraCT |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| 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 | 1 |
| E.8.9.1 | In the Member State concerned months | |
| E.8.9.1 | In the Member State concerned days | |
