Summary
|
|
---|---|
EudraCT Number: | 2008-006256-22 |
Sponsor's Protocol Code Number: | 0701104 |
National Competent Authority: | France - ANSM |
Clinical Trial Type: | EEA CTA |
Trial Status: | Ongoing |
Date on which this record was first entered in the EudraCT database: | 2008-10-31 |
Trial results |
Expand All
Collapse All
A. Protocol Information
|
|||
---|---|---|---|
A.1 | Member State Concerned | France - ANSM | |
A.2 | EudraCT number | 2008-006256-22 | |
A.3 | Full title of the trial |
|
|
A.4.1 | Sponsor's protocol code number | 0701104 | |
A.7 | Trial is part of a Paediatric Investigation Plan | Information not present in EudraCT | |
A.8 | EMA Decision number of Paediatric Investigation Plan |
B. Sponsor Information
|
||
---|---|---|
B.Sponsor: 1 | ||
B.1.1 | Name of Sponsor | CHU Saint-Etienne |
B.1.3.4 | Country | France |
B.3.1 and B.3.2 | Status of the sponsor | Non-Commercial |
B.4 Source(s) of Monetary or Material Support for the clinical trial: | ||
B.4.1 | Name of organisation providing support | |
B.4.2 | Country | |
B.5 Contact point designated by the sponsor for further information on the trial | ||
B.5.1 | Name of organisation | |
B.5.2 | Functional name of contact point |
D. IMP Identification
|
||
---|---|---|
D.IMP: 1 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | No |
D.2.1.1.1 | Trade name | remicade |
D.2.1.1.2 | Name of the Marketing Authorisation holder | CENTOCOR BV |
D.2.1.2 | Country which granted the Marketing Authorisation | France |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Intravenous infusion |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intravenous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | infliximab |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | No |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | Yes |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | Information not present in EudraCT |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | Yes |
D.3.11.13.1 | Other medicinal product type | monoclonal antibody |
D.IMP: 2 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | No |
D.2.1.1.1 | Trade name | humira |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Abbott Laboratories Ltd |
D.2.1.2 | Country which granted the Marketing Authorisation | France |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Injection* |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Subcutaneous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | adalimumab |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 40 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | No |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | Yes |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | Information not present in EudraCT |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | Yes |
D.3.11.13.1 | Other medicinal product type | monoclonal antibody |
D.IMP: 3 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | enbrel |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Wyeth Europa Ltd. |
D.2.1.2 | Country which granted the Marketing Authorisation | France |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Injection* |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Subcutaneous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | etanercept |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 25 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | No |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | Yes |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | Information not present in EudraCT |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.8 Information on Placebo
|
---|
E. General Information on the Trial
|
||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
E.1 Medical condition or disease under investigation | ||||||||||||||
E.1.1 | Medical condition(s) being investigated |
|
||||||||||||
MedDRA Classification | ||||||||||||||
E.1.2 Medical condition or disease under investigation | ||||||||||||||
|
||||||||||||||
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 |
|
||||||||||||
E.2.2 | Secondary objectives of the trial |
|
||||||||||||
E.2.3 | Trial contains a sub-study | No | ||||||||||||
E.3 | Principal inclusion criteria |
|
||||||||||||
E.4 | Principal exclusion criteria |
|
||||||||||||
E.5 End points | ||||||||||||||
E.5.1 | Primary end point(s) |
|
||||||||||||
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 | Information not present in EudraCT | ||||||||||||
E.6.5 | Efficacy | No | ||||||||||||
E.6.6 | Pharmacokinetic | Yes | ||||||||||||
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 | No | ||||||||||||
E.8.1.1 | Randomised | Information not present in EudraCT | ||||||||||||
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 | Information not present in EudraCT | ||||||||||||
E.8.1.5 | Parallel group | Information not present in EudraCT | ||||||||||||
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) | Information not present in EudraCT | ||||||||||||
E.8.2.2 | Placebo | Information not present in EudraCT | ||||||||||||
E.8.2.3 | Other | Information not present in EudraCT | ||||||||||||
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 | |||||||||||||
E.8.9.1 | In the Member State concerned months | 18 | ||||||||||||
E.8.9.1 | In the Member State concerned days |
F. Population of Trial Subjects
|
||
---|---|---|
F.1 Age Range | ||
F.1.1 | Trial has subjects under 18 | No |
F.1.1.1 | In Utero | No |
F.1.1.2 | Preterm newborn infants (up to gestational age < 37 weeks) | No |
F.1.1.3 | Newborns (0-27 days) | No |
F.1.1.4 | Infants and toddlers (28 days-23 months) | No |
F.1.1.5 | Children (2-11years) | No |
F.1.1.6 | Adolescents (12-17 years) | No |
F.1.2 | Adults (18-64 years) | Yes |
F.1.3 | Elderly (>=65 years) | No |
F.2 Gender | ||
F.2.1 | Female | Yes |
F.2.2 | Male | Yes |
F.3 Group of trial subjects | ||
F.3.1 | Healthy volunteers | No |
F.3.2 | Patients | Yes |
F.3.3 | Specific vulnerable populations | No |
F.3.3.1 | Women of childbearing potential not using contraception | Information not present in EudraCT |
F.3.3.2 | Women of child-bearing potential using contraception | Information not present in EudraCT |
F.3.3.3 | Pregnant women | Information not present in EudraCT |
F.3.3.4 | Nursing women | Information not present in EudraCT |
F.3.3.5 | Emergency situation | Information not present in EudraCT |
F.3.3.6 | Subjects incapable of giving consent personally | Information not present in EudraCT |
F.3.3.7 | Others | Information not present in EudraCT |
F.4 Planned number of subjects to be included | ||
F.4.1 | In the member state | 20 |
G. Investigator Networks to be involved in the Trial
|
---|
N. Review by the Competent Authority or Ethics Committee in the country concerned
|
||
---|---|---|
N. | Competent Authority Decision | Authorised |
N. | Date of Competent Authority Decision | 2008-11-21 |
N. | Ethics Committee Opinion of the trial application | Favourable |
N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion |
|
N. | Date of Ethics Committee Opinion | 2008-02-11 |
P. End of Trial
|
||
---|---|---|
P. | End of Trial Status | Ongoing |