- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02636907
Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe
Assessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously With an Autoinjector in Patients With Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered With a Prefilled Syringe
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
-
Bialystok, Pologne, 15-099
- Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
-
Bydgoszcz, Pologne, 85-168
- Szpital Uniwersytecki nr 2 im.dr J. Biziela
-
Elblag, Pologne, 82-300
- Wojewodzki Szpital Zespolony w Elblagu
-
Gdynia, Pologne, 81-338
- Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
-
Katowice, Pologne, 40-954
- Medical Centre Pratia Katowice I
-
Krakow, Pologne, 30-002
- Medical Centre Pratia Krakow
-
Krakow, Pologne, 31-023
- Specialist Center ALL-MED, Krakow
-
Torun, Pologne, 87-100
- Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
-
Warszawa, Pologne, 01-868
- Medical Centre Pratia Warszawa
-
Wroclaw, Pologne, 51-128
- Wojewodzki Szpital Specjalistyczny We Wroclawiu
-
-
-
-
California
-
Upland, California, États-Unis, 91786
- Inland Rheumatology Clinical Trials, Inc.
-
-
Florida
-
Venice, Florida, États-Unis, 34292
- Lovelace Scientific Resources, Incorporated
-
-
Maryland
-
Cumberland, Maryland, États-Unis, 21502
- Klein and Associates, M.D., P.A.
-
-
Massachusetts
-
Worcester, Massachusetts, États-Unis, 01605
- Clinical Pharmacology Study Group
-
-
New Mexico
-
Albuquerque, New Mexico, États-Unis, 87102
- Albuquerque Center for Rheumatology
-
-
Texas
-
Dallas, Texas, États-Unis, 75231
- Metroplex Clinical Research Center
-
Houston, Texas, États-Unis, 77065
- Rheumatology Clinic of Houston, P.A.
-
Lubbock, Texas, États-Unis, 79424
- Arthritis & Osteoporosis Associates LLP
-
Nassau Bay, Texas, États-Unis, 77058
- Heartland Research Associates, LLC
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion criteria:
- Moderately to severely active Rheumatoid arthritis (RA) for at least 6 months, which is not adequately controlled by non-biologics DMARDs.
- No contraindications to anti-Tumor necrosis factor (TNF) agents.
- Either biologics naive or biologics-experienced but with no experience of self-administration medication using autoinjector or pen.
- Patients must be able and willing to self-inject BI 695501. Further inclusion criteria apply.
Exclusion criteria:
- Experience with self-administration of medication using an autoinjector or pen.
- American College of Rheumatology functional Class IV or wheelchair/ bed bound.
- Primary or secondary immunodeficiency.
- History of tuberculosis (TB). Further exclusion criteria apply.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: BI 695501
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Autoinjector Assessment Period: Percentage of Successful Self-injections as Reported in the Questionnaires Completed by Both the Trial Site Personnel and the Patient Analysing All Self-injections
Délai: Up to Day 50.
|
The percentage of successful self-injections as reported in the questionnaires completed by both the trial site personnel and the patient during the Autoinjector Assessment Period analyzing all self-injections occurring after the training self-injection up to the EoT Visit. Successful self-injections were based on the response to Question 2 (Q2) on the questionnaire, which queried whether the full content of the autoinjector was injected into the body. An injection was considered successful when both the patient and the qualified trial site personnel responded yes to the Q2 on their respective questionnaires. If they responded no to Q2, patients and trial site personnel were instructed to also answer Question 3, which asked what prevented the patient for injecting the full contents of the autoinjector. Planned injections after discontinuation from the trial were not included in the analysis. Percentage of injections calculated relative to the total number of first injections. |
Up to Day 50.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events
Délai: Up to Day 50.
|
The percentage of any autoinjector handling event during the self-injection process included any one of the following events which prevented the patient from successfully self-injecting the full content of the autoinjector and which occurred after the training self-injection up to the EoT Visit: removing the cap of the autoinjector (3a); pressing the injection button of the autoinjector (3b); or holding the autoinjector down against the skin until the injection is completed (3c). Percentage of injections was calculated relative to the total number of injections (both unsuccessful and successful). |
Up to Day 50.
|
Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions
Délai: Up to 17 weeks.
|
Qualified trial site personnel contacted the patient 48 hours after each self-injection during the autoinjector assessment period to collect all Adverse Events (AEs), including injection-site reactions. Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period. Percentage of subjects calculated relative to the total number of subjects in the analysis set. |
Up to 17 weeks.
|
Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment
Délai: Up to 17 weeks.
|
A treatment-related TEAE was defined as any TEAE assessed by the investigator as related to the trial medication.
Data is reported for the autoinjector assessment period.
TEAEs were defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive.
The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included).
If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.
|
Up to 17 weeks.
|
Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions
Délai: up to Week 60
|
The percentage of patients with local injection site reactions in the Autoinjector assessment period and Extension Phase.
In Extension phase, patients were given diaries to record events between each site visit during extension phase.
Patients were instructed to accurately record the following on the diary cards: the dates & times of BI 695501 dosing; problems encountered with dosing; the occurrence of any AEs; the use of concomitant therapies; and the PFS storage conditions.
Patients were instructed to contact the site if they experienced any AEs between designated site visits.
In Extension phase Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first PFS administration date (Day 57 visit) and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period.
Percentage of subjects calculated relative to the total number of subjects in the analysis set
|
up to Week 60
|
Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment
Délai: up to Week 60
|
The percentage of patients with drug-related adverse events as per investigator in the Autoinjector assessment period and Extension Phase.
In Extension phase, Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication and prior to the last date of trial medication during Extension phase treatment period + 10 weeks (70 days) inclusive.
The Extension phase treatment period started on the first PFS administration date (Day 57 visit) and ended on Day 351 visit date (included).
Thus If a TEAE occurred from the first PFS administration and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period.
|
up to Week 60
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1297.11
- 2015-003030-27 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur BI 695501 Autoinjector
-
Boehringer IngelheimComplété
-
Boehringer IngelheimComplétéArthrite, rhumatoïdeÉtats-Unis, Espagne, Corée, République de, Thaïlande, Malaisie, Pologne, Fédération Russe, Serbie, Bulgarie, Chili, Estonie, Allemagne, Hongrie, Ukraine
-
Boehringer IngelheimComplétéMaladie de CrohnSerbie, Royaume-Uni, États-Unis, Tchéquie, Allemagne, Grèce, Pologne, Fédération Russe, Turquie, Israël, Biélorussie, Ukraine, Croatie, Bosnie Herzégovine
-
Boehringer IngelheimComplétéPsoriasisÉtats-Unis, Pologne, Hongrie, Allemagne, Lettonie, Fédération Russe, Ukraine
-
Boehringer IngelheimComplétéPsoriasisÉtats-Unis, Allemagne, Fédération Russe, Tchéquie, Pologne, Ukraine, Estonie, Slovaquie
-
Boehringer IngelheimComplétéArthrite, rhumatoïdeEspagne, États-Unis, Corée, République de, Malaisie, Pologne, Thaïlande, Bulgarie, Chili, Estonie, Allemagne, Hongrie, Nouvelle-Zélande, Fédération Russe, Serbie, Ukraine
-
Boehringer IngelheimComplété
-
Boehringer IngelheimRecrutementMélanome | Cancer du poumon non à petites cellules (NSCLC) | Carcinome épidermoïde de la tête et du cou (HNSCC)Pays-Bas
-
Boehringer IngelheimPas encore de recrutement
-
Boehringer IngelheimComplété