Clinical Trials Register

Summary
EudraCT Number:	2019-003662-40
Sponsor's Protocol Code Number:	UKER-AMGEVITA-CED-NOVO-01
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-10-22
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - PEI

A.2

EudraCT number

2019-003662-40

A.3

Full title of the trial

Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis)

Prospektive, offene, einarmige, monozentrische klinische Prüfung der Phase IV zur Untersuchung der Wirksamkeit und Sicherheit des Adalimumab Biosimilar Amgevita® bei Patienten mit mittelschwerer bis schwerer aktiver chronisch entzündlicher Darmerkrankung (Morbus Crohn und Colitis ulcerosa)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

Amgevita de novo in CED

A.4.1

Sponsor's protocol code number

UKER-AMGEVITA-CED-NOVO-01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Universitätsklinikum Erlangen
B.1.3.4	Country	Germany
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	Amgen GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universitätsklinikum Erlangen
B.5.2	Functional name of contact point	Medizinische Klinik 1
B.5.3	Address:
B.5.3.1	Street Address	Ulmenweg 18
B.5.3.2	Town/ city	Erlangen
B.5.3.3	Post code	91054
B.5.3.4	Country	Germany
B.5.6	E-mail	markus.neurath@uk-erlangen.de

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	Yes
D.2.1.1.1	Trade name	Amgevita 40 mg Injektionslösung in einer Fertigspritze
D.2.1.1.2	Name of the Marketing Authorisation holder	AMGEN GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
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.3.9.1	CAS number	331731-18-1
D.3.9.4	EV Substance Code	SUB20016
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	Yes
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.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	Yes
D.2.1.1.1	Trade name	Amgevita 40 mg Injektionslösung im Fertigpen
D.2.1.1.2	Name of the Marketing Authorisation holder	AMGEN GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
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.3.9.1	CAS number	331731-18-1
D.3.9.4	EV Substance Code	SUB20016
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	Yes
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

E.1.1.1

Medical condition in easily understood language

Moderate to severe active chronic inflammatory bowel disease

Mittelschwere bis schwere aktive chronisch entzündliche Darmerkrankung

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10021972
E.1.2	Term	Inflammatory bowel disease
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To investigate efficacy of adalimumab biosimilar (Amgevita) in subjects with moderate to severe active chronic inflammatory bowel disease (Crohn's disease and ulcererative colitis)

Nachweis der Wirksamkeit von Adalimumab-Biosimilar (Amgevita®) bei Patienten mit mittelschweren bis schweren aktiven CED (M. Crohn und Colitis ulcerosa)

E.2.2

Secondary objectives of the trial

- To investigate efficacy of adalimumab biosimilar (Amgevita) in subjects To investigate efficacy of adalimumab biosimilar (Amgevita) in subjects with moderate to severe active chronic inflammatory bowel disease (Crohn's disease and ulcererative colitis)
- Relation between adalimumab-auto antibody and response to therapy
- Relation between adalimumab plasma levels and disease activity
- Evaluation of quality of life under therapy with Amgevita
- Estimation of disease activity in relation to fecal calprotectin level
- safety and tolerability of adalimumab biosimilar (Amgevita) in subjects with moderate to severe active chronic inflammatory bowel disease (Crohn's disease and ulcererative colitis)

 Untersuchung der Wirksamkeit von Adalimumab-Biosimilar (Amgevita®) bei Patienten mit mittelschwerer bis schwerer aktiver CED im Untersuchungszeitraum
 Untersuchung des Zusammenhangs von Adalimumab-Autoantikörpern und Therapieansprechen
 Untersuchung des Zusammenhangs von Adalimumab-Plasmaspiegel und Krankheitsaktivität
 Beurteilung der Lebensqualität unter der Therapie mit Amgevita®
 Abschätzung der Krankheitsaktivität anhand der fäkalen Calprotectinkonzentration
 Sicherheit und Verträglichkeit von Adalimumab-Biosimilar (Amgevita®) bei Patienten mit mittelschweren bis schweren aktiven CED im Untersuchungszeitraum

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Evaluation of suitability of fMRI for the prediction of the response to adalimumab therapy early in initial treatment with the adalimumab biosimilar (Amgevita)

Überprüfung der Eignung von fMRT zur Prädiktion des Ansprechens auf die Therapie mit Adalimumab bei Neueinstellung auf das Adalimumab-Biosimilar (Amgevita®)

E.3

Principal inclusion criteria

1. Age: 18-80 years
2. Male or female
3. Subject is mentally able to understand the nature and content of the clinical trial and to follow the instructions of the study staff
4. Existence of a written informed consent
5. Diagnosis of chronic inflammatory bowel disease with indication for initial treatment with adalimumab in subjects with moderate to high grade disease activity and clinically insufficient response to or contraindication for systematic therapy with corticosteroids and/ or immunosuppressants, as defined below:
Current diagnosis of moderate to severe, ulcerative colitis with a total Mayo score of ≥6 (endoscopic subscore of ≥2) that has been confirmed in accordance with the current guidelines of the DGVS and ECCO and has been in existence for at least 3 months.
OR
Current diagnosis of a moderate to severe active M. Crohn with a Harvey-Bradshaw index of ≥8 months, which has been confirmed in accordance with the current guidelines of the DGVS and ECCO and has been in existence for at least 3 months.
AND
insufficient response or intolerance to conventional therapy (including oral 5-ASA supplements, oral glucocorticoids, azathiopurine, 6-mercaptopurine or methothrexate)
6. If concomitant therapy is necessary, then under the following conditions:
a. Systemic therapy with glucocorticoids: stable dosage for at least two weeks before screening
b. MMX budesonide (9 mg/day), stable osage for 4 weeks before screening
c. 5-aminosalicylates: stable dosage for at least two weeks and initiated for at least 8 weeks before screening
d. Immunosuppressants (except ciclosporin A and tacrolimus): therapy for at least three months and stable dosage for at least four weeks before screening
7. Existence of endoscopic diagnostics taking into account the individual infestation pattern of the patient. The last endoscopic findings may have been collected no more than 12 weeks before the screening.
8. Female participants of child bearing potential must also meet at least one of the following criteria:
- menopause (at least 12 months of natural amenorrhea or six months of amenorrhea with serum-FSH >40mU/ml) or
- condition after ovarectomy or hysterectomy on both sides for at least six weeks before the screening date (visit 1, day -7-6 days) or
- Regular, correct and reliable use of a method of contraception with a failure rate of 1% per year (e.g. implants, depot syringes, intrauterine pessar, hormonal spirals) or
- partner's vasectomy.

1. Alter: 18-80 Jahre
2. Männliche oder weibliche Person
3. Der Patient ist mental in der Lage, Wesen und Inhalt der klinischen Prüfung zu verstehen und die Anweisungen des Studienpersonals zu befolgen.
4. Vorliegen der schriftlichen Einwilligung des Patienten nach erfolgter Aufklärung durch den Prüfer bzw. ein ärztliches Mitglied der Prüfgruppe.
5. Diagnose einer CED mit Indikation zur Neueinstellung auf Adalimumab bei mittel- bis hochgradiger Krankheitsaktivität und klinisch ungenügendem Ansprechen auf bzw. Kontraindikationen gegen eine systemische Therapie mit Glukokortikoiden und/oder Immunsuppressiva, wie folgt definiert
Aktuelle, entsprechend den aktuellen Leitlinien der DGVS und ECCO gesicherte und mindestens seit 3 Monaten bestehende Diagnose einer mittelschweren bis schweren, aktiven Colitis ulcerosa mit einem totalen Mayo Score von ≥6 (endoskopischer Subscore von ≥2)
ODER
Aktuelle entsprechend den aktuellen Leitlinien der DGVS und ECCO gesicherte und mindestens seit 3 Monaten bestehende Diagnose eines mittelschweren bis schweren, aktiven M. Crohn mit einem Harvey-Bradshaw-Index von ≥8
UND
kein ausreichendes Ansprechen oder eine Unverträglichkeit auf eine konventionelle Therapie (einschließlich orale 5-ASA-Präparate, orale Glukokortikoide, Azathioprin, 6-Mercaptopurin oder Methothrexat)
6. Falls Begleittherapie vorhanden, dann unter den folgenden Bedingungen:
a. Systemische Therapie mit Glukokortikoiden: stabil über mindestens zwei Wochen vor dem Screening
b. MMX Budesonid (9 mg/Tag), stabil seit 4 Wochen vor Screening
c. 5-Aminosalizylate: stabile Dosierung seit mindestens zwei Wochen und initiiert seit mindestens 8 Wochen vor Screening
d. Immunsuppressiva (außer Ciclosporin A und Tacrolimus): Therapie seit mindestens drei Monaten und dabei stabile Dosierung über mindestens vier Wochen vor Screening
7. Vorliegen der endoskopischen Diagnostik unter Berücksichtigung des individuellen Befallsmusters des Patienten. Die letzten endoskopischen Befunde dürfen maximal 12 Wochen vor dem Screening erhoben worden sein.
8. Teilnehmerinnen müssen zusätzlich mindestens eines der folgenden Kriterien erfüllen:
- Menopause (mindestens zwölf Monate natürliche Amenorrhoe oder sechs Monate Amenorrhoe mit Serum-FSH >40mU/ml) oder
- Zustand nach beidseitiger Ovarektomie oder Hysterektomie seit mindestens sechs Wochen vor dem Screening-Termin (Visite 1, Tag -7±6 Tage) oder
- Regelmäßige, korrekte und verlässliche Anwendung einer Verhütungsmethode mit einer Fehlerquote ≤1% pro Jahr (z.B. Implantate, Depotspritzen, Intrauterinpessar, Hormonspiralen) oder
- Vasektomie des Partners.

E.4

Principal exclusion criteria

1. Known contraindications for adalimumab therapy:
- Known hypersensitivity to any of the ingredients of the investigational medicinal product or to medicinal products with a similar chemical structure
- Moderate to severe heart failure (NYHA III/IV).
- Active tuberculosis.
- Severe acute infection including sepsis.
- Acute opportunistic infections including invasive fungal infections.
2. Acute or chronic infection with hepatitis B
3. Known demyelinating diseases of the central and peripheral nervous system (e.g. multiple sclerosis, Guillain-Barré syndrome)
4. Malignant disease (active malignancy under ongoing oncological therapy or a recent malignancy with moderate to high risk of recurrence within the last 5 years prior to screening)
5. The existence of another serious disease which, at the discretion of the investigator would result in a disproportionate risk to the patient concerned
6. Pregnancy and lactation
7. Administration of other anti-TNF-Ak therapies, ustekinumab, vedolizumab or tofacitinib within the last 4 weeks prior to study inclusion
8. Administration of ciclosporin A or tacrolimus within the last 8 weeks prior to study inclusion in a non-stable dose
9. Therapy with Anakinra or Abatacept
10. Planned surgical intervention during the study period such as colectomy, installation of an ileo-anal pouche, an ileorectostomy or an ileostoma
11. Persons who are dependent or employed by the sponsor or investigator.
12. Planned longer stay outside the region, which prevents compliance with the visit plan.
13. Participation in another clinical trial or administration of an unauthorised active substance within the last 4 weeks prior to the screening date.

1. Vorliegen einer bekannten Kontraindikation für eine Therapie mit Adalimumab:
- Bekannte Überempfindlichkeit gegenüber einem der Inhaltsstoffe des Prüfpräparats oder gegenüber Arzneimittel mit ähnlicher chemischer Struktur
- Mäßige bis schwere Herzinsuffizienz (NYHA III/IV).
- Aktive Tuberkulose.
- Schwere akute Infektion einschließlich Sepsis.
- Akute opportunistische Infektionen einschließlich invasiver Pilzinfektionen.
2. Akute oder chronische Infektion mit Hepatitis B
3. Bekannte demyelinisierende Erkrankungen des zentralen und peripheren Nervensystems (z.B. Multiple Sklerose, Guillain-Barré-Syndrom)
4. Maligne Erkrankung (aktives Malignom unter laufender onkologischer Therapie oder ein rezentes Malignom mit mäßigem bis hohem Rezidivrisiko innerhalb der letzten 5 Jahre vor dem Screening)
5. Vorliegen einer sonstigen schwerwiegenden Erkrankung, durch welche nach Ermessen des beurteilenden Arztes ein Studieneinschluss ein unverhältnismäßig hohes Risiko für den betroffenen Patienten darstellen würde
6. Schwangerschaft und Stillzeit
7. Gabe sonstiger anti-TNF-Ak-Therapien, Ustekinumab, Vedolizumab oder Tofacitinib innerhalb der letzten 4 Wochen vor Studieneinschluss
8. Gabe von Ciclosporin A oder Tacrolimus innerhalb der letzten 8 Wochen vor Studieneinschluss in nicht stabiler Dosierung
9. Therapie mit Anakinra oder Abatacept
10. Geplanter chirurgischer Eingriff während des Studienzeitraums wie z.B. Kolektomie, Anlage eines ileo-analen Pouches, einer Ileorektostomie oder eines Ileostomas
11. Personen, die in einen Abhängigkeits- oder Arbeitsverhältnis zum Sponsor oder Prüfer stehen.
12. Geplanter längerer Aufenthalt außerhalb der Region, der die Einhaltung des Visitenplans verhindert.
13. Teilnahme an einer anderen klinischen Prüfung oder Verabreichung eines nicht zugelassenen Wirkstoffs innerhalb der letzten 4 Wochen vor dem Screening-Termin.

E.5 End points

E.5.1

Primary end point(s)

Clinical response to adalimumab biosimilar therapy (Amgevita®) at the time 13±1 weeks after the onset of therapy in patients with moderate to severe active CED (Crohn's disease and ulcerative colitis)

Klinisches Ansprechen auf die Therapie mit dem Adalimumab-Biosimilar (Amgevita®) zum Zeitpunkt 13±1 Wochen nach Therapiebeginn bei Patienten mit einer mittelschweren bis schweren aktiven CED (M. Crohn und Colitis ulcerosa)

E.5.1.1

Timepoint(s) of evaluation of this end point

At the time 13±1 weeks after onset of therapy

13±1 Wochen nach Therapiebeginn

E.5.2

Secondary end point(s)

• Clinical response to therapy with adalimumab biosimilar (amgevita®) at time 14±3 days, 26±3 weeks, 39±3 weeks and 52±3 weeks after initiation of therapy in patients with moderate to severe active chronic IBD (Crohn's disease and ulcerative colitis)
•Clinical remission with adalimumab biosimilar (amgevita®) at the time of 13±1 week, 26±3 weeks, 39±3 weeks and 52±3 weeks after initiation of therapy in patients with moderate to severe active IBD (Crohn's disease and ulcerative colitis)
• Clinical response to therapy with adalimumab biosimilar (Amgevita®) at the time of 14±3 days, 26±3 weeks, 39±3 weeks and 52±3 weeks after initiation of therapy in patients with moderate to severe ulcerative colitis
•Clinical response to therapy with adalimumab biosimilar (Amgevita®) at the time of 14±3 days, 26±3 weeks, 39±3 weeks and 52±3 weeksafter the start of therapy in patients with moderate to severe active Crohn's disease
• Maintenance of clinical response or remission with adalimumab biosimilar (Amgevita®) in patients with IBD (Crohn's disease, ulcerative colitis) at the time of 26±3 weeks, 39±3 weeks and 52±3 weeks after the start of therapy
• Assessment of the quality of life on the basis of the IBDQ questionnaire on the day of the start of therapy with Amgevita® (day 1) and at the time 13±1 week, 26±3 weeks, 39±3 weeks and 52±3 weeks after the start of therapy
• Estimation of disease activity based on calprotectin concentration in the stool prior to the onset of therapy with adalimumab biosimilar (amgevita®) and at times 13±1 weeks, 26±3 weeks, and 52±3 weeks after the start of therapy
• Adalimumab valley levels in the serum at the time of 14±3 days, 13±1, 26±3, 39±3 and 52±3 weeks after the start of therapy
Concentration of antibodies against serum adalimumab in serum at time 14±3 days, 13±1, 26±3, 39±3 and 52±3 weeks after the start of therapy
• Occurrence of AEs, ARs, SAEs and SARs during the observation period (day 1 after administration of the IMP up to 52±3 weeks after the start of therapy)

 Klinisches Ansprechen auf die Therapie mit Adalimumab-Biosimilar (Amgevita®) zum Zeitpunkt 14±3 Tage, 26±3 Wochen, 39±3 Wochen und 52±3 Wochen nach Therapiebeginn bei Patienten mit einer mittelschweren bis schweren aktiven CED (M. Crohn oder Colitis ulcerosa)
 Klinische Remission unter der Therapie mit Adalimumab-Biosimilar (Amgevita®) zum Zeitpunkt 13±1 Wochen, 26±3 Wochen, 39±3 Wochen und 52±3 Wochen nach Therapiebeginn bei Patienten mit einer mittelschweren bis schweren aktiven CED (M. Crohn oder Colitis ulcerosa)
 Klinisches Ansprechen auf die Therapie mit Adalimumab-Biosimilar (Amgevita®) zum Zeitpunkt 14±3 Tage, 26±3 Wochen, 39±3 Wochen und 52±3 Wochen nach Therapiebeginn bei Patienten mit einer mittelschweren bis schweren aktiven Colitis ulcerosa
 Klinisches Ansprechen auf die Therapie mit Adalimumab-Biosimilar (Amgevita®) zum Zeitpunkt 14±3 Tage, 26±3 Wochen, 39±3 Wochen und 52±3 Wochen nach Therapiebeginn bei Patienten mit einem mittelschweren bis schweren aktiven M. Crohn
 Aufrechterhaltung des klinischen Ansprechens3 bzw. Remission unter Therapie mit Adalimumab-Biosimilar (Amgevita®) bei Patienten mit einer CED (M. Crohn, Colitis ulcerosa) zum Zeitpunkt 26±3 Wochen, 39±3 Wochen und 52±3 Wochen nach Therapiebeginn
 Beurteilung der Lebensqualität anhand des IBDQ Fragebogens am Tag des Therapiebeginns mit Amgevita® (Tag 1) und zum Zeitpunkt 13±1, 26±3, 39±3 und 52±3 Wochen nach Therapiebeginn
 Abschätzung der Krankheitsaktivität anhand der Calprotectin-Konzentration im Stuhl vor Therapiebeginn mit Adalimumab-Biosimilar (Amgevita®) sowie zum Zeitpunkt 13±1, 26±3 und 52±3 Wochen nach Therapiebeginn
 Adalimumab-Talspiegel im Serum zum Zeitpunkt 14±3 Tage, 13±1, 26±3, 39±3 und 52±3 Wochen nach Therapiebeginn
 Konzentration von Antikörpern gegen Adalimumab im Serum zum Zeitpunkt 14±3 Tage, 13±1, 26±3, 39±3 und 52±3 Wochen nach Therapiebeginn
 Auftreten von AEs, ARs, SAEs und SARs im Beobachtungszeitraum (Tag 1 nach Applikation des Prüfpräparates bis 52±3 Wochen nach Therapiebeginn)

E.5.2.1

Timepoint(s) of evaluation of this end point

14±3 days, 13±1, 26±3, 39±3 and 52±3 weeks after onset of therapy

14±3 Tage, 13±1, 26±3, 39±3 und 52±3 Wochen nach Therapiebeginn

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

LPLV

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

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

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

standard therapy

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-11-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-12-18

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-03-07

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IMP with orphan designation in the indication
Orphan Designation Number:
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