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Molecular Effects of Apremilast in the Synovium of Psoriatic Arthritis Patients (MEAS)

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ClinicalTrials.gov Identifier: NCT04645420
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : November 27, 2020
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
This study assess the genomics profiles in synovial biopsies obtained prior to, and 24 weeks after an immunomodulator agent (Apremilast) in patients with active psoriatic arthritis who are naive to treatment with a conventional synthetic DMARDs (such as methotrexate).

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Procedure: Global gene expression profiles obtained from synovial biopsies. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Molecular Effects of Apremilast in the Synovium of Psoriatic Arthritis Patients (MEAS Study)
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: Apremilast

15 PsA patients with active disease and naïve to conventional synthetic and biologic disease modifying anti-rheumatic drugs.

Treatment with apremilast orally in the whole group (n = 15). Escalating dose the first Week (10 mg once day1, 10 mg bid day2, 10 mg-20 mg day3, 20 mg bid day4, 20 mg-30 mg day5, 30 mg bid on day6), and 30 mg bid from day7 until week24.

Procedure: Global gene expression profiles obtained from synovial biopsies.
Global gene expression profiles obtained from synovial biopsies before and after 24 weeks of treatment with the drug in each patient.
Other Name: No other intervention




Primary Outcome Measures :
  1. Quantitative measurement of the molecular changes in relation to the up-regulated or down-regulated genes in the synovium. [ Time Frame: 24 weeks ]

    The primary endpoint of the study is not the efficacy of the drug, but the molecular changes it induce in the synovium.

    In a first set of analyses, the magnitude of fold-changes in global gene expression profiles between baseline and W24 will be analysed. The higher values correspond to the high intensity in the up-regulation or down-regulation of the gene expression.



Secondary Outcome Measures :
  1. Comparison between the magnitude of molecular changes (up-regulation or down-regulation of the genes) and clinical changes (improvement or worsening of the swollen joints count). [ Time Frame: 24 weeks ]
    The swollen joints count (0 to 66) will be assessed. Lowered scores correspond to an improvement (remission or low disease activity), and increased value to a worsening of the clinical conditions (high disease activity). The value of the joints count will be compared to the magnitude of the up-regulation or down-regulation in the gene expression profiles.

  2. Comparison between the magnitude of molecular changes (up-regulation or down-regulation of the genes) and imaging changes on Grey Scale ultrasound (GSUS). [ Time Frame: 24 weeks ]
    Synovitis (inflammation in the synovium) is scored by US in Grey-Scale (GS) (0 to 3). 0 correspond to lack of inflammation, and 3 to high amount of inflammation. The US changes in GS will be compared to the magnitude of up-regulation or down-regulation in the gene expression profiles.

  3. Comparison between the magnitude of molecular changes (up-regulation or down-regulation of the genes) and imaging changes on Power Doppler ultrasound (PDUS). [ Time Frame: 24 weeks ]
    Synovitis (inflammation in the synovium) is scored by US with the Power Doppler (PD) (0 to 3). 0 correspond to lack of inflammation, and 3 to high amount of inflammation. The US changes in PD will be compared to the magnitude of up-regulation or down-regulation in the gene expression profiles.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients who meet ALL the following criteria can be enrolled:

  • Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
  • Male or non-pregnant, non-nursing female patients at least 18 years of age.
  • With a diagnosis of active PsA according to CASPAR criteria
  • Naïve to csDMARD and bDMARD,
  • At least 1 swollen joint at screening or baseline (despite NSAIDs therapy) with ability to perform a synovial biopsy at W0.
  • Concomitant oral steroids (no more than 10 mg/day of prednisolone), NSAIDs, or painkillers is permitted if started prior to the study and remain at a stable dose at least 4 weeks before the baseline.
  • Allowed concomitant medications are to remain stable through week 24.
  • At least one joint (small or large) to biopsy in order to get synovial tissue. Small joints must have an US scoring > 2 on grey-scale score/power Doppler.

Exclusion Criteria:

Patients who meet AT LEAST one of the following exclusion criteria will be excluded:

  • Contraindications for needle-arthroscopy.
  • Patients with hypersensitivity to apremilast or to one of its excipients
  • Prior csDMARD or bDMARD therapy,
  • Women who are pregnant, breastfeeding or planning on becoming pregnant for the 24 weeks of the drug administration,
  • Non-menopausal women who are not using an adequate contraception method,
  • Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint
  • Impossibility to meet specific protocol requirements (e.g. blood sampling)
  • Patient is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
  • Uncooperative or any condition that could make the patient potentially noncompliant to the study procedures
  • Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline.
  • Any intramuscular corticosteroid injection within 4 weeks before baseline.
  • A history of active tuberculosis (TB).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645420


Contacts
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Contact: Adrien NZEUSSEU TOUKAP, MD +32.2.764.11.11 ext 4.9389 Adrien.Nzeusseu@uclouvain.be
Contact: Charlene MOUAFO TOUKAM, MS +32.2.764.53.96 ext 4.5396 Charlene.Mouafo@uclouvain.be

Locations
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Belgium
Adrien NZEUSSEU TOUKAP Recruiting
Brussels, Belgium, 1200
Contact: Adrien NZEUSSEU TOUKAP, MD    +32.2.764.11.11 ext 4.9389    Adrien.Nzeusseu@uclouvain.be   
Contact: Charlene MOUAFO TOUKAM, MS    +32.2.764.53.96 ext 4.5396    Charlene.Mouafo@uclouvain.be   
Principal Investigator: Adrien NZEUSSEU TOUKAP, MD         
Sub-Investigator: Maria STOENOIU, MD, PhD         
Sub-Investigator: Laurent MERIC de BELLEFON, MD         
Sub-Investigator: Patrick DUREZ, MD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Amgen
Investigators
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Principal Investigator: Adrien NZEUSSEU TOUKAP, MD Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Additional Information:
Publications:

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT04645420    
Other Study ID Numbers: P1200_46
AP-CL-PSA-PI-13146 ( Other Grant/Funding Number: AMGEN )
2019-003887-39 ( EudraCT Number )
2020/24AOU/424 ( Other Identifier: Ethic committee - Institutional Review Board )
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Biologics
Apremilast
Synovium
Genomics
Psoriatic disease
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases