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EUCTR2018-003351-37 | SNCTP000003484

Studie zu Baricitinib (LY3009104) bei Erwachsenen mit Rheumatoider Arthritis

Data source: BASEC (Imported from 28.05.2020), WHO (Imported from 22.03.2020)
Changed: 12.05.2020
Disease category: Anderes

Brief description of trial (Source of data: BASEC)

Dies ist eine internationale medizinisch-wissenschaftliche Studie, an der rund 2600 Patientinnen und Patienten mit Rheumatoider Arthritis teilnehmen werden, darunter 18 Patienten in der Schweiz. Die Dauer der Studie umfasst 2.5 bis 5.5 Jahre. Sollten bereits nach 2.5 Jahren genügend Erkenntnisse zum Studienmedikament vorliegen, wird die Studie nicht weiter fortgeführt. Ziel ist es festzustellen, wie sicher das Studienmedikament Baricitinib ist und welche Nebenwirkung die Einnahme hat. Das Studienmedikament wird verglichen mit Tumornekrosefaktor-Hemmern. Es wird per Zufall entschieden welche Behandlung die Patienten erhalten (Baricitinib, oder Tumornekrosefaktor-Hemmer).
Studienablauf
Teilnehmer/innen werden gebeten entweder das Studienmedikament, oder das Vergleichsmedikament einzunehmen. Der Prüfarzt/Äzrtin wird besprechen, wie und in welchen Abständen das Medikament eingenommen wird. Nach der ersten Einnahme des Studienmedikamentes, sind weitere Besuche im Studienzentrum nach 12 Wochen und 28 Wochen geplant. Danach werden Teilnehmer/innen gebeten alle 24 Wochen ins Studienzentrum zu kommen. An den Besuchen wird der Prüfarzt/Ärztin die Teilnehmer untersuchen, es werden Blut- und Urinproben genommen und die Teilnehmer/innen werden gebeten Fragen zum allgemeinen Wohlbefinden zu beantworten.

Health conditions investigated (Source of data: BASEC)

Rheumatoide Arthritis

Health conditions (Source of data: WHO)

Rheumatoid Arthritis
MedDRA version: 21.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Baricitinib - 2mg und 4 mg Tabletten im Vergleich zu Tumornekrosefaktor-Hemmern.

Interventions (Source of data: WHO)


Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BARICITINIB
CAS Number: 1187594-09-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-

Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BARICITINIB
CAS Number: 1187594-09-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Trade Name: Enbrel
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Criteria for participation in trial (Source of data: BASEC)

Patienten die an Rheumatoider Arthritis leiden und mindestens 18 Jahre alt sind.

Exclusion criteria (Source of data: BASEC)

Eine Teilnahme ist nicht möglich wenn die Patienten:
- schwanger sind oder stillen
- Patienten die Gürtelrose oder an einer schweren Infektion / Erkrankung leiden
- Patienten die an Krebs leiden

Inclusion/Exclusion Criteria (Source of data: WHO)

Inclusion criteria:
Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic).
Participants must have at least one of the following characteristics:
•Documented evidence of a VTE prior to this study
•At least 60 years of age or older
• A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m2), or
•Age 50 to less than 60 years AND BMI 25 to less than 30 kg/m2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2080
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 520

Exclusion criteria:
•Participants must not have any problems taking a tumor necrosis factor (TNF) inhibitor, baricitinib, the active substance, or any of the excipients listed in the SmPC Section 6.1.
•Participants must not be pregnant or breastfeeding.
•Participants must not have had more than one VTE.
•Participants must not have cancer.
•Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness. This is also applicable to patients with evidence of HIV infection and/or who are positive for anti-HIV antibodies.
•Participants must not have had a live vaccine within four weeks of study start.
•Participants must not have participated in any other clinical trial within four weeks of study randomisation.
•Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003351-37

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2018-003351-37-PL

Further information on trial

Date trial registered

09.08.2019

Incorporation of the first participant

04.09.2019

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Source of data: WHO)

A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE

Type of trial (Source of data: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Source of data: WHO)


Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Blinded core study team members
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 3

Phase (Source of data: WHO)

Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): yes

Primary end point (Source of data: WHO)

Main Objective: To compare baricitinib (combined dose groups) to TNF inhibitors with respect to the risk of VTE.;
Secondary Objective: •To compare baricitinib (combined dose groups) to TNF inhibitors with respect to the risk of key safety outcomes.
•To compare each baricitinib dose to TNF inhibitors with respect to the risk of key safety outcomes.
;Primary end point(s): Time from first dose of study treatment to first event of Venous thromboembolism (VTE).;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated at week 12, week 28, week 52 and every 24 weeks thereafter.

Secundary end point (Source of data: WHO)

Timepoint(s) of evaluation of this end point: Endpoints will be evaluated at week 12, week 28, week 52 and every 24 weeks thereafter (all visits after randomisation). ;
Secondary end point(s): Time from first dose of study treatment (combined baricitinib doses compared to TNF inhibitors) to first event of:
Arterial thromboembolic event (ATE)
Major adverse cardiovascular events (MACE)
Malignancy (excluding Nonmelanoma skin cancer(NMSC))
Opportunistic infection
Serious infection

Time from first dose of study treatment (each individual baricitinib dose compared to TNF inhibitor) to first event
of:
VTE
ATE
MACE
Malignancy (excluding NMSC)
Opportunistic infection
Serious infection

Contact information (Source of data: WHO)

Eli Lilly and Company

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Basel, Freiburg, St Gallen

Countries (Source of data: WHO)

Australia, Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

Prof. Dr. Diego Kyburz
+41 61 265 90 27
diego.kyburz@usb.ch

Contact for general information (Source of data: WHO)

Clinical Trial Registry Office
Lilly Corporate Center, DC 1526
Eli Lilly
EU_Lilly_Clinical_Trials@lilly.com

Contact for scientific information (Source of data: WHO)

Clinical Trial Registry Office
Lilly Corporate Center, DC 1526
Eli Lilly
EU_Lilly_Clinical_Trials@lilly.com

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Eli Lilly and Company

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2019-00874

Secondary ID (Source of data: WHO)

I4V-MC-JAJA;NCT03915964;2018-003351-37-GB