Kliinilise uuringu otsus nr RKU-4/35

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

24.05.2024 nr RKU-4/35

OTSUS

Ravimi kliinilise uuringu loa andmiseks Euroopa Parlamendi ja nõukogu määruse (EL) nr

536/2014 (määrus (EL) 536/2014) alusel

Uuringu sponsor Janssen - Cilag International, keda käesolevas menetluses esindab Parexel

International, esitas 15.04.2024 Ravimiametile taotluse ravimi kliinilise uuringu teostamiseks

määruse (EL) 536/2014 artikli 5 (1) ja ravimiseaduse (RavS) § 991 lõikes 1 sätestatud

tingimustel.

Tuginedes määruse (EL) 536/2014 artiklile 8, hindamisaruande I ja II osaga hõlmatud aspekte

hinnates, otsustab Ravimiamet ravimiseaduse § 996 lg 1 punkti 1 ja lõike 3 alusel

anda uuringu sponsorile Janssen - Cilag International loa ravimi kliinilise uuringu

läbiviimiseks vastavalt esitatud uuringuplaanile nr 78934804CRD2001 järgmistel

tingimustel:

uuringuplaani number: 78934804CRD2001 (versioon 3.0 kuupäevaga 29. juuni 2023)

uuringu referentsnumber: 22-041

uuringu nimetus: „A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled,

Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and

Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with

Moderately to Severely Active Crohn’s Disease“

uuringu sponsor: Janssen - Cilag International

uuritavate arv Eestis: 5

vastutavad uurijad ja uuringukeskused:

- Dr Karin Kull, Tartu Ülikooli Kliinikum, L. Puusepa tn 8, 50406 Tartu, Eesti

- Dr Külliki Suurmaa, Lääne-Tallinna Keskhaigla AS, Paldiski mnt 68, 10617 Tallinn,

Eesti

- Dr Peeter Kõiva, Ida-Tallinna Keskhaigla, Ravi tn 18, 10138 Tallinn, Eesti

Gabriele Jurksaite

Parexel International

Kestucio 65/40

LT-08124 Vilnius

LEEDU

2 (2)

Vaide käesolevale otsusele saab esitada Ravimiametile 30 päeva jooksul arvates otsuse

teatavaks tegemisest vastavalt haldusmenetluse seaduse § 71 lõikele 1. Kui otsuse saaja soovib

otsust vaidlustada halduskohtus, võib ta vastavalt halduskohtumenetluse seadustiku § 7 lõikele

1 ja § 46 lõikele 1 esitada kaebuse otsuse peale Tartu Halduskohtule 30 päeva jooksul otsuse

teatavaks tegemisest arvates.

Lugupidamisega

(allkirjastatud digitaalselt)

Ott Laius

Peadirektori asetäitja

peadirektori ülesannetes

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

24.05.2024 nr RKU-4/35

DECISION

to grant authorisation for clinical trial on the basis of Regulation (EU) No 536/2014 of the

European Parliament and of the council

State Agency of Medicines has received the application from sponsor Janssen - Cilag

International on 15.04.2024 to conduct a clinical trial under the conditions stipulated in

Regulation (EU) No 536/2014 art 5 (1) and § 991 (1) of Estonian Medicinal Products Act

(MPA).

Based on art 8 of Regulation (EU) No 536/2014, considering the aspects covered by Part I and

Part II of the assessment report, on the basis of § 996 section 1 p 1 and (3) of Medicinal Product

Act

State Agency of Medicines has decided to give the approval to conduct the clinical study

protocol no 78934804CRD2001 under the following conditions:

protocol no: 78934804CRD2001 (Version 3.0, dated June 29, 2023)

full title of the trial: A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled,

Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and

Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with

Moderately to Severely Active Crohn’s Disease

sponsor of the trial: Janssen - Cilag International

number of subjects in Estonia: 5

principal investigators and study locations:

- Dr Karin Kull, Tartu University Hospital, L. Puusepa tn 8, 50406 Tartu, Estonia

- Dr Külliki Suurmaa, Lääne-Tallinna Keskhaigla AS, Paldiski mnt 68, 10617 Tallinn,

Estonia

- Dr Peeter Kõiva, East Tallinn Central Hospital, Ravi tn 18, 10138 Tallinn, Estonia

The addressee may file a challenge with State Agency of Medicines within 30 days as of the

day when the addressee became or should have become aware of the decision as prescribed in

Code of Administrative Procedure § 71(1). If the addressee wishes to have the decision to

Gabriele Jurksaite

Parexel International

Kestucio 65/40

LT-08124 Vilnius

LITHUANIA

2 (2)

annulled by the administrative court, he or she may submit a complaint to the Tartu

Administrative Court as prescribed in § 7(1) and § 46(1) of the Code of Administrative Court

Procedure within 30 days after the date on which the decision was notified to the applicant.

(digitally signed)

Ott Laius

Deputy Director General

on duties of Director General