Kliinilise uuringu otsus nr RKU-4/27

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

29.04.2024 nr RKU-4/27

OTSUS

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

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

Uuringu sponsor Dr Reddy's Laboratories Limited, keda käesolevas menetluses esindab

Reddy Holding GmbH, esitas 28.12.2023 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 Dr Reddy's Laboratories Limited loa ravimi kliinilise uuringu

läbiviimiseks vastavalt esitatud uuringuplaanile nr AB-01-004 järgmistel tingimustel:

uuringuplaani number: AB-01-004 (versioon 2.0-EU-V1.0 kuupäevaga 29. märts 2024)

uuringu referentsnumber: 23-042

uuringu nimetus: „A randomised, double-blind, multicentre study comparing the efficacy,

safety and immunogenicity of proposed Abatacept biosimilar (DRL_AB) with Orencia®

administered by the intravenous route as an add-on to methotrexate in the treatment of

patients with moderate to severe rheumatoid arthritis“

uuringu sponsor: Dr Reddy's Laboratories Limited

uuritavate arv Eestis: 14

uuringu algus: mai 2024

vastutavad uurijad ja uuringukeskused:

- Dr Airi Põder, Kliiniliste Uuringute Keskus OÜ, Sõbra tn 54/1, 50106 Tartu, Eesti

- Dr Ene Ojassalu, sihtasutus Põhja-Eesti Regionaalhaigla, J. Sütiste tee 19, 13419

Tallinn, Eesti

- Dr Sandra Meisalu, Innomedica OÜ, Narva mnt 7, 10117 Tallinn, Eesti

- Dr Raili Müller, MediTrials OÜ, Mõisavahe tn 34c, 50708 Tartu, Eesti

Juliette Omtzigt

Reddy Holding GmbH

Kobelweg 95 Kriegshaber

86156 Augsburg

SAKSAMAA

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)

Katrin Kiisk

Peadirektor

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

29.04.2024 nr RKU-4/27

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 Dr Reddy's Laboratories

Limited on 28.12.2023 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 AB-01-004 under the following conditions:

protocol no: AB-01-004 (Version 2.0-EU-V1.0, dated March 29, 2024)

full title of the trial: A randomised, double-blind, multicentre study comparing the efficacy,

safety and immunogenicity of proposed Abatacept biosimilar (DRL_AB) with Orencia®

administered by the intravenous route as an add-on to methotrexate in the treatment of patients

with moderate to severe rheumatoid arthritis

sponsor of the trial: Dr Reddy's Laboratories Limited

number of subjects in Estonia: 14

starting date: May 2024

principal investigators and study locations:

- Dr Airi Põder, Kliiniliste Uuringute Keskus OÜ, Sõbra tn 54/1, 50106 Tartu, Estonia

- Dr Ene Ojassalu, North Estonia Medical Centre Foundation, J. Sütiste tee 19, 13419

Tallinn, Estonia

- Dr Sandra Meisalu, Innomedica OÜ, Narva mnt 7, 10117 Tallinn, Estonia

- Dr Raili Müller, MediTrials OÜ, Mõisavahe tn 34c, 50708 Tartu, Estonia

Juliette Omtzigt

Reddy Holding GmbH

Kobelweg 95 Kriegshaber

86156 Augsburg

GERMANY

2 (2)

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

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)

Katrin Kiisk

Director General