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Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis (SELECTED)

11 avril 2018 mis à jour par: Biogen

A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)

Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS) relapse, slowing disability progression, and reducing new MS lesion formation in this study population.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This study will provide participants who complete Study 205MS202 (NCT00870740) with the option to receive continued open-label Daclizumab High Yield Process (DAC HYP) monotherapy and to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Approximately 60 to 100 participants will be enrolled into an optional open-label, 16-week autoinjector substudy at a selected subset of sites which will run concurrently during the main study, and will evaluate the systemic exposure and local tolerability of subcutaneous administration of DAC HYP by autoinjector. The 2013-2014 trivalent influenza vaccine will be offered to all eligible participants as an optional substudy to assess the effect of DAC-HYP treatment on the immune response to vaccination,

Type d'étude

Interventionnel

Inscription (Réel)

410

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Bayreuth, Allemagne, 95445
        • Research Site
      • Erlangen, Allemagne, 91054
        • Research Site
      • Marburg, Allemagne, 35043
        • Research Site
      • Rostock, Allemagne, 18147
        • Research Site
  • Fédération Russe
      • Kazan, Fédération Russe, 420021
        • Research Site
      • Krasnoyarsk, Fédération Russe, 660049
        • Research Site
      • Moscow, Fédération Russe, 107150
        • Research Site
      • Moscow, Fédération Russe, 115682
        • Research Site
      • Moscow, Fédération Russe, 6127018
        • Research Site
      • Nizhniy Novgorod, Fédération Russe, 603076
        • Research Site
      • Novosibirsk, Fédération Russe, 630087
        • Research Site
      • Omsk, Fédération Russe, 644033
        • Research Site
      • Samara, Fédération Russe, 443095
        • Research Site
      • Smolensk, Fédération Russe, 214018
        • Research Site
      • St Petersburg, Fédération Russe, 194291
        • Research Site
      • Ufa, Fédération Russe, 450005
        • Research Site
      • Yaroskavi, Fédération Russe, 150030
        • Research Site
  • Hongrie
      • Budapest, Hongrie, 1083
        • Research Site
      • Budapest, Hongrie, 1115
        • Research Site
      • Budapest, Hongrie, 1125
        • Research Site
      • Budapest, Hongrie, 1076
        • Research Site
      • Budapest, Hongrie, 1134
        • Research Site
      • Debrecen, Hongrie, 4032
        • Research Site
      • Esztergom, Hongrie, 2500
        • Research Site
      • Gyor, Hongrie, 9024
        • Research Site
      • Kecskemet, Hongrie, 6000
        • Research Site
      • Miskolc, Hongrie, 3526
        • Research Site
      • Miskolc, Hongrie, 3533
        • Research Site
      • Nyiregyhaza, Hongrie, 4400
        • Research Site
      • Siofok, Hongrie, 8600
        • Research Site
  • Inde
      • Bangalore, Inde, 560034
        • Research Site
      • Hyderabad, Inde, 500082
        • Research Site
      • Kolkata, Inde, 700068
        • Research Site
      • Mumbai, Inde, 400012
        • Research Site
      • Rajasthan, Inde, 302021
        • Research Site
  • Pologne
      • Bialystok, Pologne, 15-276
        • Research Site
      • Bialystok, Pologne, 15-420
        • Research Site
      • Gdansk, Pologne, 80-803
        • Research Site
      • Katowice, Pologne, 40-749
        • Research Site
      • Katowice, Pologne, 40-752
        • Research Site
      • Krakow, Pologne, 31-505
        • Research Site
      • Lodz, Pologne, 93-121
        • Research Site
      • Lublin, Pologne, 20954
        • Research Site
      • Warsaw, Pologne, 02-957
        • Research Site
      • Warszawa, Pologne, 02-097
        • Research Site
  • Royaume-Uni
      • London, Royaume-Uni, SE59RF
        • Research Site
      • Nottingham, Royaume-Uni, NG72UH
        • Research Site
      • Plymouth, Royaume-Uni, PL68DH
        • Research Site
      • Sheffield, Royaume-Uni, S102JF
        • Research Site
      • Stoke-on-Trent, Royaume-Uni, ST47LN
        • Research Site
  • Tchéquie
      • Brno, Tchéquie, 625 00
        • Research Site
      • Brno, Tchéquie, 656 91
        • Research Site
      • Hradec Kralove, Tchéquie, 500 02
        • Research Site
      • Prague, Tchéquie, 100 34
        • Research Site
      • Teplice, Tchéquie, 415 29
        • Research Site
  • Ukraine
      • Chernivtsi, Ukraine, 58018
        • Research Site
      • Dnipropetrovsk, Ukraine, 49027
        • Research Site
      • Donetsk, Ukraine, 83003
        • Research Site
      • Kharkiv, Ukraine, 61068
        • Research Site
      • Kiev, Ukraine, 03110
        • Research Site
      • Kiev, Ukraine, 2125
        • Research Site
      • Kyiv, Ukraine, 03110
        • Research Site
      • Poltava, Ukraine, 36024
        • Research Site
      • Zaporizhia, Ukraine, 69035
        • Research Site
      • Zaporizhia, Ukraine, 69600
        • Research Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Main Study Eligibility:

Key Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  • Subjects who have completed 52 weeks in Study 205MS202 (NCT00870740) and were compliant with the 205MS202 protocol in the opinion of the Investigator.
  • Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.

Key Exclusion Criteria:

  • Subjects with any significant change in their medical status from the previous study that would prelude administration of Daclizumab High Yield Process (DAC HYP) as determined by the Investigator including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in the 205MS201 (NCT00390221) or 205MS202 (NCT00870740) studies. The Investigator must re-review the subject's medical fitness for participation and must consider any diseases that would preclude treatment.
  • Any subject who has permanently discontinued study treatment in Study 205MS202 (NCT00870740) due to an adverse event.
  • Current enrollment in any investigational drug study other than Study 205MS202 (NCT00870740).
  • Ongoing treatment with any approved or experimental disease-modifying treatment for multiple sclerosis.

  • For subjects currently taking valproic acid, carbamazepine, lamotrigine, or phenytoin:

    • Subjects treated with any of these agents for fewer than 6 months prior to study entry are excluded from study participation unless they discontinue the agent(s) prior to study entry.
    • Subjects treated with 2 or more of these agents for more than 6 months prior to study entry are excluded from study participation unless they reduce to ≤1 agent prior to study entry.
    • Subjects who have had dose escalations of one of these agents within the 6 months prior to study entry are excluded from study participation unless they revert to a previous dose that had been used for at least 6 months prior to study entry or unless they discontinue the agent prior to study entry
  • Subjects who are currently receiving treatment with isoniazid, propylthiouracil, or nimesulide at the time of study entry and are not able to discontinue the agent or change to an alternative medication allowed by the protocol.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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: BIIB019
Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 288.
Biologique: BIIB019 (Daclizumab)
Administered as specified in the treatment arm.
Autres noms:
  • Processus à haut rendement du daclizumab
  • CAD HYP
Biologique: trivalent seasonal influenza vaccine
All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs
Délai: Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)
Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab
Délai: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
Délai: From Baseline through 288 weeks
New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader.
From Baseline through 288 weeks
Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
Délai: From Baseline through 288 weeks
New or newly enlarging T2 hyperintense lesions evaluated by MRI and analyzed by a central reader.
From Baseline through 288 weeks
Number of Participants With Total Number of New Gadolinium-enhancing Lesions
Délai: From Baseline through 288 weeks
New Gadolinium-enhancing lesions was evaluated by MRI and analyzed by a central reader.
From Baseline through 288 weeks
Annual Change in Number of T1 Hypointense Lesions
Délai: From Baseline through 288 weeks
From Baseline through 288 weeks
Annual Change in Volume of New Gadolinium-Enhancing Lesions
Délai: From Baseline through 288 weeks
From Baseline through 288 weeks
Annual Change in Volume of T1 Hypointense Lesions
Délai: From Baseline through 288 weeks
Volume of T1 hypointense lesions was evaluated by MRI and analyzed by a central reader.
From Baseline through 288 weeks
Percent Change in Total Brain Volume
Délai: From Baseline through 288 weeks
To assess brain atrophy, total brain volume was be measured by MRI and analyzed by a central reader.
From Baseline through 288 weeks
Number of Participants With Antibodies to DAC HYP
Délai: Up to Week 288
Up to Week 288
Annualized Relapse Rate (ARR)
Délai: Week 288
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365. Adjusted ARR was reported.
Week 288
Number of Participants With Sustained Disability Progression for 12 Weeks
Délai: Week 48 up to Week 288
Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 12 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.
Week 48 up to Week 288
Number of Participants With Sustained Disability Progression for 24 Weeks
Délai: Week 48 up to Week 288
Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.
Week 48 up to Week 288
Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab
Délai: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4
Délai: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4
Délai: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
Participant-Reported Pain Visual Analog Scale (VAS) Score
Délai: First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose
The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end ("0 [no pain]" on the left and "100 [very painful]" on the right). The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain.
First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose
Summary of Injection Site Assessment Performed by Clinician
Délai: First injection (Day 1) and fourth injection (Day 90) 30 minutes; 8, 24, 72, and 120 hours; and 7, 10, and 14 days post-dose

Injection site assessment was performed by clinician and are defined as erythema (redness) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; pigmentation changes (skin discoloration other than redness) rated on a 3 point scale from 0-2, where 0=none, 1=hypopigmentation and 2=hyperpigmentation; induration (swelling) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; tenderness to pressure rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; and local temperature changes of injection sites rated on a 3 point scale where 0=normal, 1=warm and 1=hot. Only those score categories for which there was at least 1 participant are reported.

Here, Injection=Inj, post-dose=PD
First injection (Day 1) and fourth injection (Day 90) 30 minutes; 8, 24, 72, and 120 hours; and 7, 10, and 14 days post-dose

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Biogen

Collaborateurs

AbbVie

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

31 mars 2010

Achèvement primaire (Réel)

25 août 2016

Achèvement de l'étude (Réel)

25 août 2016

Dates d'inscription aux études

Première soumission

15 janvier 2010

Première soumission répondant aux critères de contrôle qualité

15 janvier 2010

Première publication (Estimation)

18 janvier 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 novembre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 avril 2018

Dernière vérification

1 avril 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 205-MS-203
  • 2009-015318-23 (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 .

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