Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis (ROC-SPA)

June 6, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease characterized by inflammatory arthritis and enthesitis involving the spine. AxSpA prevalence is around 0.17% of the French population. Tumor necrosis factor (TNF) was the first target defined in axSpA. Since one third of axSpA patients failed to the first TNF blocker, many axSpA patients received a second biological Disease-Modifying AntiRheumatic Drugs (bDMARDs). Until few months, the only choice was to use a second TNF blocker.Since 2003, pharmaceutical companies investigated efficacy of TNF blockers already used in rheumatoid arthritis. Etanercept is a fusion protein with TNF receptor type II p75 and IgG1 Fc fragment, whereas adalimumab, infliximab, and golimumab are monoclonal antibodies. Certolizumab is a fusion between a fab fragment targeting TNF and a Peg fraction. All demonstrated efficacy versus placebo in a randomized double blinded study

In case of failure to the first TNF blockers, rheumatologists will follow the "Treat-to-Target" principle. This approach already demonstrated its benefit in rheumatoid arthritis or in psoriatic arthritis. This concept was also suggested for axSpA with low levels of evidence and recommendation. So rheumatologist will provide the best treatment in case of failure to the first TNF blockers, which is a daily clinical situation. Since few months, rheumatologists have the choice between targeting IL-23/17 axis compared to a second TNF blocker.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France
        • Recruiting
        • CHU d'Angers
        • Contact:
        • Principal Investigator:
          • Erick LEGRAND, PhD
      • Besançon, France
        • Recruiting
        • CHRU Besançon
        • Contact:
          • Daniel Wendling, MD
        • Principal Investigator:
          • Daniel Wendling, MD
        • Sub-Investigator:
          • Clément PRATI, MD
        • Sub-Investigator:
          • Xavier GUILLOT, MD
        • Sub-Investigator:
          • Frank VERHOEVEN, PhD
      • Bobigny, France
        • Not yet recruiting
        • APHP- Hôpital Avicenne
        • Principal Investigator:
          • Luca SEMERANO, MD
      • Bordeau, France
        • Recruiting
        • CHU Bordeaux
        • Contact:
          • Thierry Schaeverbeke, MD
        • Principal Investigator:
          • Thierry Schaeverbeke, MD
      • Brest, France
        • Recruiting
        • CHRU Brest
        • Contact:
          • Valérie Devauchelle, MD
        • Principal Investigator:
          • Valérie Devauchelle, MD
        • Sub-Investigator:
          • Dewi GUELLEC, MD
        • Sub-Investigator:
          • Alain SARAUX, MD
        • Sub-Investigator:
          • Maxime QUIVIGER, MD
      • Clermont-Ferrand, France
        • Recruiting
        • Chu Clermont-Ferrand
        • Contact:
          • Anne Tournadre, MD
        • Principal Investigator:
          • Anne Tournadre, MD
      • Grenoble, France
        • Recruiting
        • CHU de Grenoble Alpes
        • Principal Investigator:
          • Athan BAILLET, MD PhD
        • Sub-Investigator:
          • Philippe GAUDIN, MD
      • La Roche-sur-Yon, France
        • Recruiting
        • CHD Vendee
        • Principal Investigator:
          • Grégoire CORMIER, MD
        • Sub-Investigator:
          • Vincent ANDRE, MD
        • Sub-Investigator:
          • Michel CAULIER, MD
        • Sub-Investigator:
          • Céline COZIC, MD
        • Sub-Investigator:
          • Emeline GAIGNEUX, MD
        • Sub-Investigator:
          • Alexia MICHAUT, MD
        • Sub-Investigator:
          • Stéphane VARIN, MD
      • Le Mans, France
        • Recruiting
        • CH Le Mans
        • Principal Investigator:
          • Emmanuelle DERNIS, MD
        • Contact:
          • Emmanuelle Dernis, MD
        • Sub-Investigator:
          • Amélie Denis, MD
        • Sub-Investigator:
          • Guillaume Diriez, MD
        • Sub-Investigator:
          • Arthur VRIGNAUD, MD
      • Lille, France
        • Not yet recruiting
        • CHRU Lille
        • Contact:
          • René-Marc Flipo, MD
        • Principal Investigator:
          • RENE-MARC FLIPO, MD
      • Lomme, France
        • Recruiting
        • Hôpital Saint-Philibert
        • Principal Investigator:
          • Tristan PASCART, MD PhD
        • Sub-Investigator:
          • Aurore PACAUD, MD
      • Lyon, France
        • Recruiting
        • Hôpital Edouard Herriot
        • Principal Investigator:
          • Roland CHAPURLAT, MD
        • Sub-Investigator:
          • Florence DUVERT, MD
      • Lyon, France
        • Recruiting
        • CH Lyon sud
        • Principal Investigator:
          • Fabienne COURY, MD
        • Sub-Investigator:
          • Mathilde PRORIOL, MD
      • Montpellier, France
        • Recruiting
        • CHRU Montpellier
        • Contact:
          • Cédric Lukas, MD
        • Principal Investigator:
          • Cédric Lukas, MD
      • Montpellier, France
        • Recruiting
        • CHU Montpellier - 2 - Unité Clinique thérapeutique des Maladies Ostéo-Articulaires
        • Principal Investigator:
          • Christian JORGENSEN, MD
        • Sub-Investigator:
          • Rosanna FERREIRA LOPEZ, MD
        • Sub-Investigator:
          • Yves-Marie PERS, MD
      • Nancy, France
        • Recruiting
        • Chu Nancy
        • Contact:
          • Damien Loeuille, MD
        • Principal Investigator:
          • Damien LOEUILLE, MD
      • Nantes, France
        • Recruiting
        • CHU de Nantes
        • Contact:
          • Benoît Le Goff, MD
        • Principal Investigator:
          • Benoît Le Goff, MD
        • Sub-Investigator:
          • Thomas Garraud, MD
        • Sub-Investigator:
          • Yves Maugars, MD
      • Nice, France
        • Recruiting
        • CHU de Nice
        • Contact:
          • Christian Roux, MD
        • Principal Investigator:
          • Christian Roux, MD
      • Orléans, France
        • Recruiting
        • CHR d'Orléans
        • Contact:
          • Eric Lespessailles, MD
        • Principal Investigator:
          • Eric Lespessailles, MD
        • Sub-Investigator:
          • Alexei Volguine, MD
      • Paris, France
        • Recruiting
        • APHP - Hôpital Ambroise Paré
        • Contact:
          • Maxime Breban, MD
        • Principal Investigator:
          • Maxime Breban, MD
        • Sub-Investigator:
          • Ariane Leboime Grigaut, MD
      • Paris, France
        • Not yet recruiting
        • APHP - Hôpital BICHAT
        • Contact:
          • Philippe Dieudé, MD
        • Principal Investigator:
          • Philippe Dieudé, MD
      • Paris, France
        • Recruiting
        • APHP - Hôpital Cochin
        • Contact:
          • Corinne Miceli, MD
        • Principal Investigator:
          • Corinne Miceli, MD
      • Paris, France
        • Not yet recruiting
        • APHP - Hôpital Lariboisière
        • Contact:
          • Pascal Richette, MD
        • Principal Investigator:
          • Pascal Richette, MD
      • Paris, France
        • Recruiting
        • APHP - Hôpital Saint-Antoine
        • Contact:
          • Jérémie Sellam, MD
        • Principal Investigator:
          • Jérémie SELLAM, MD
        • Sub-Investigator:
          • Camille DEPROUW, MD
        • Sub-Investigator:
          • Sandra DESOUCHES, MD
      • Paris, France
        • Recruiting
        • APHP - Hopital Henri Mondor
        • Contact:
          • Pascal Claudepierre, MD
        • Principal Investigator:
          • Pascal Claudepierre, MD
      • Paris, France
        • Recruiting
        • APHP - Hôpital Pitié-Salpêtrière
        • Contact:
          • Laure Gossec
        • Principal Investigator:
          • Laure Gossec, MD
        • Sub-Investigator:
          • Béatrice Banneville, MD
      • Paris, France
        • Recruiting
        • APHP - Kremlin-Bicêtre
        • Contact:
          • Stephan Pavy, MD
        • Principal Investigator:
          • Stephan Pavy, MD
        • Sub-Investigator:
          • Rabika Belkhir, MD
        • Sub-Investigator:
          • Frédéric Desmoulins, MD
        • Sub-Investigator:
          • Julien Henry, MD
        • Sub-Investigator:
          • Gaetane Nocturne, MD
        • Sub-Investigator:
          • Raphaèle Seror, MD
      • Poitiers, France
        • Recruiting
        • CHU de Poitiers
        • Contact:
          • Elisabeth Solau, MD
        • Principal Investigator:
          • Elisabeth Solau, MD
      • Reims, France
        • Recruiting
        • CHU Reims
        • Principal Investigator:
          • Jean-Hugues SALMON, MD PhD
        • Sub-Investigator:
          • Loïs BOLKO, MD
        • Sub-Investigator:
          • Isabelle CHARLOT LAMBRECHT, MD
        • Sub-Investigator:
          • Marion GEOFFROY, MD
        • Sub-Investigator:
          • Ambre HITTINGER-ROUX, MD
        • Sub-Investigator:
          • Loïc PAUVELE, MD
      • Rouen, France
        • Recruiting
        • CHU de Rouen
        • Contact:
          • Thierry Lequerré, MD
        • Principal Investigator:
          • Thierry Lequerré, MD
        • Sub-Investigator:
          • Sophie Pouplin, MD
      • Saint-Étienne, France, 42055
        • Recruiting
        • CHU Saint-Etienne
        • Contact:
        • Principal Investigator:
          • Hubert MAROTTE, MD
      • Strasbourg, France, 67200
        • Recruiting
        • CHU Strasbourg - Hautepierre
        • Contact:
          • Renaud FELTEN, MD
        • Principal Investigator:
          • Renaud FELTEN, MD
      • Toulouse, France
        • Recruiting
        • CHU Toulouse
        • Contact:
          • Arnaud Constantin, MD
        • Principal Investigator:
          • Arnaud Constantin, MD
      • Tours, France
        • Recruiting
        • CHRU Tours
        • Principal Investigator:
          • Philippe Goupille, MD
        • Sub-Investigator:
          • Saloua Mammou-Mraghni, MD
        • Sub-Investigator:
          • Jessica RENE, MD
  • Monaco
      • Monaco, Monaco
        • Recruiting
        • CH Princesse de Grace
        • Contact:
          • Olivier Brocq, MD
        • Principal Investigator:
          • Olivier BROCQ, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Active axSPA with BASDAI>4 or ASDAS>3.5, who need change in TNF blocker treatment
  • Aged over 18 years
  • Inadequate response after at least 3 months to the 1st TNF blocker
  • If non biologic DMARD treatment : stable dose for at least on month before inclusion
  • If oral corticosteroids treatment : stable dose for at least on month before inclusion
  • If NSAIDs treatment : stable dose for at least on month before inclusion
  • Ability to complete questionnaires
  • Social security affiliation
  • Informed written consent given

Exclusion Criteria:

  • Any contra-indication to TNF blocker and/or secukinumab
  • Inflammatory bowel diseases
  • Existing pregnancy, lactation, or intended pregnancy within the next 15 months Active tuberculosis or other severe infections such as sepsis or opportunistic infections
  • Active infections, including chronic or localised infections.
  • Moderate to severe heart failure (NYHA classes III/IV)
  • Impossibility to give informed consent
  • Impossibility to be followed for 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: targeting IL-23/17 axis

The experimental group (targeting IL-23/17 axis) receiving secukinumab in compliance with the marketing authorization regimen: 150 mg per week for 5 weeks, and then every month by subcutaneous injection.

Blood specimen at each visits
Drug: Secukinumab
Secukinumab : 150 mg per week for 5 weeks, and then every month by subcutaneous injection
Biological: blood specimen
Blood specimen at each visits for measurement of bDMARS blockers concentration and anti-drug antibody concentration
Active Comparator: TNF blocker

• The control group receiving a second TNF blocker in compliance with the marketing authorization regimen:

The TNF blocker (originator or biosimilar) will be different to the TNF used before the inclusion and will be chose by the investigator:

  • infliximab: 5mg/kg per IV infusion at weeks 0, 2, 6, and then every 6 weeks,
  • etanercept: 50mg per week in subcutaneous injection,
  • adalimumab: 40mg every other week in subcutaneous injection,
  • certolizumab: 400mg every other week 3 times, and then 200mg every other week or 400mg per month in subcutaneous injections,
  • golimumab: 50mg every month in subcutaneous injection, in case of overweight (>100kg) an inadequate response, 100mg every month is allow.

Blood specimen at each visits
Biological: blood specimen
Blood specimen at each visits for measurement of bDMARS blockers concentration and anti-drug antibody concentration
Drug: TNF blocker

TNF blocker (originator or biosimilar) :

  • infliximab: 5mg/kg per IV infusion at weeks 0, 2, 6, and then every 6 weeks,
  • etanercept: 50mg per week in subcutaneous injection,
  • adalimumab: 40mg every other week in subcutaneous injection,
  • certolizumab: 400mg every other week 3 times, and then 200mg every other week or 400mg per month in subcutaneous injections,
  • golimumab: 50mg every month in subcutaneous injection, in case of overweight (>100kg) an inadequate response, 100mg every month is allow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of axSpA patients with a clinical response Assessments in Ankylosing Spondylitis International Society 40 (ASAS 40) at week 24
Time Frame: 24 weks

ASAS 40 is defined as an improvement of at least 40% and absolute improvement of at least 2 units on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion:

  • Patient global assessment : numerical rating scale with extremes labelled "none" and "severe."
  • Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain."
  • Function : BASFI average of 10 questions measured by numerical rating scale with extremes labelled "easy" and "impossible."
  • Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening at all in remaining domain
24 weks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of axSpA patients with a clinical response ASAS 40 at week 12
Time Frame: 12 weeks

ASAS 40 is defined as an improvement of at least 40% and absolute improvement of at least 2 units on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion:

  • Patient global assessment : numerical rating scale with extremes labelled "none" and "severe."
  • Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain."
  • Function : BASFI average of 10 questions measured by numerical rating scale with extremes labelled "easy" and "impossible."
  • Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening at all in remaining domain
12 weeks
Proportion of axSpA patients with a clinical response ASAS 40 at week 52
Time Frame: 52 weeks

ASAS 40 is defined as an improvement of at least 40% and absolute improvement of at least 2 units on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion:

  • Patient global assessment : numerical rating scale with extremes labelled "none" and "severe."
  • Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain."
  • Function : BASFI average of 10 questions measured by numerical rating scale with extremes labelled "easy" and "impossible."
  • Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening at all in remaining domain
52 weeks
Proportion of axSpA patients with a clinical response ASAS 20 at week 12
Time Frame: 52 weeks

ASAS 20 is defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion:

  • Patient global assessment : numerical rating scale with extremes labelled "none" and "severe."
  • Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain."
  • Function : BASFI average of 10 questions regarding measured by numerical rating scale with extremes labelled "easy" and "impossible."
  • Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening in a similar amount in the fourth domain
52 weeks
Proportion of axSpA patients with a clinical response ASAS 20 at week 24
Time Frame: 24 weeks

ASAS 20 is defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion:

  • Patient global assessment : numerical rating scale with extremes labelled "none" and "severe."
  • Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain."
  • Function : BASFI average of 10 questions regarding measured by numerical rating scale with extremes labelled "easy" and "impossible."
  • Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening in a similar amount in the fourth domain
24 weeks
Proportion of axSpA patients with a clinical response ASAS20 at week 52
Time Frame: 52 weeks

ASAS 20 is defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion:

  • Patient global assessment : numerical rating scale with extremes labelled "none" and "severe."
  • Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain."
  • Function : BASFI average of 10 questions regarding measured by numerical rating scale with extremes labelled "easy" and "impossible."
  • Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening in a similar amount in the fourth domain
52 weeks
Proportion of axSpA patients with a partial remission rate at week 12
Time Frame: 12 weeks

Partial remission is defined by values lower than 2/10 in each 4 domains:

  • Patient global assessment measured on a numerical rating scale with extremes labelled "none" and "severe."
  • Pain assessment represented by the average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain."
  • Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by numerical rating scale with extremes labelled "easy" and "impossible."
  • Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI regarding morning stiffness as measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours."
12 weeks
Proportion of axSpA patients with a partial remission rate at week 24
Time Frame: 24 weeks

Partial remission is defined by values lower than 2/10 in each 4 domains:

  • Patient global assessment measured on a numerical rating scale with extremes labelled "none" and "severe."
  • Pain assessment represented by the average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain."
  • Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by numerical rating scale with extremes labelled "easy" and "impossible."
  • Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI regarding morning stiffness as measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours."
24 weeks
Proportion of axSpA patients with a partial remission rate at week 52
Time Frame: 52 weeks

Partial remission is defined by values lower than 2/10 in each 4 domains:

  • Patient global assessment measured on a numerical rating scale with extremes labelled "none" and "severe."
  • Pain assessment represented by the average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain."
  • Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by numerical rating scale with extremes labelled "easy" and "impossible."
  • Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI regarding morning stiffness as measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours."
52 weeks
Proportion of axSpA patients with a ASDAS major improvement at week 12
Time Frame: 12 weeks
ASDAS major improvement was defined by a variation of ASDAS-CRP≥2
12 weeks
Proportion of axSpA patients with a ASDAS major improvement at week 24
Time Frame: 24 weeks
ASDAS major improvement was defined by a variation of ASDAS-CRP≥2
24 weeks
Proportion of axSpA patients with a ASDAS major improvement at week 52
Time Frame: 52 weeks
ASDAS major improvement was defined by a variation of ASDAS-CRP≥2
52 weeks
Proportion of axSpA patients with biological Disease-Modifying AntiRheumatic Drugs (bDMARDs) treatment at week 12
Time Frame: 12 weeks
Patient with the same bDAMRs treatment at inclusion and week 12
12 weeks
Proportion of axSpA patients with biological Disease-Modifying AntiRheumatic Drugs (bDMARDs) treatment at week 24
Time Frame: 24 weeks
Patient with the same biological Disease-Modifying AntiRheumatic Drug (bDAMR) treatment at inclusion and week 24
24 weeks
Proportion of axSpA patients with bDMARDs treatment at week 52
Time Frame: 52 weeks
Patient with the same biological Disease-Modifying AntiRheumatic Drug (bDAMR) treatment at inclusion and week 52
52 weeks
Number of adverse events
Time Frame: 52 weeks
Number of adverse events
52 weeks
Correlation between concentration of antibodies to bDMARS blockers and clinical response according to treatment
Time Frame: From baseline to 52 weeks
Concentration of antibodies to bDMARS blockers is measured by Enzyme Linked ImmunoSorbent Assay (ELISA) low disease activity is defined by BASDAI <4 and ASDAS <2.1
From baseline to 52 weeks
Correlation between concentration of anti-drug antibodies and clinical response according to treatment
Time Frame: From baseline to 52 weeks
Concentration of anti-drug antibodies is measured by Enzyme Linked ImmunoSorbent Assay (ELISA) low disease activity is defined by BASDAI <4 and ASDAS <2.1
From baseline to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France

Investigators

  • Study Director: Hubert MAROTTE, MD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2018

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

February 20, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1608185
  • 2017-004700-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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