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Trial record 63 of 192 for:    Recruiting, Not yet recruiting, Available Studies | Pharmacology

Investigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid Arthritis (PROMETHEE)

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ClinicalTrials.gov Identifier: NCT03110094
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
Interventional study with minimal risks and constraints, prospective, mono-centric.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Adalimumab Other: Healthy volunteers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid Arthritis, With Analysis of CD4 + Follicular Helper T Subpopulations
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Rheumatoid arthritis - Adalimumab Other: Adalimumab
It will be an interventional study with minimal risks and constraints, prospective, mono-centric, in current care. Patient management will not be changed during the study. It will be taken at two different tracking points (M0 and M3) 4 additional tubes and use of surplus articular fluid (M0 and M3).
Other Name: Additional Biological Sample

Healthy volunteer Other: Healthy volunteers
Collection of 2 tubes of blood. The values of the quantitative study of lymphocyte subpopulations will be compared to those obtained from healthy blood donors to define the standards used in this study.
Other Name: Recovery of blood tubes during a donation




Primary Outcome Measures :
  1. Patient responding or not responding to treatment with Adalimumab at 6 months defined by a value of Disease Activity Score 28 (DAS 28) ≤ 3.2. [ Time Frame: 6 months ]
    Disease Activity Score 28 (DAS 28) calculated in every patients after clinical examination.


Secondary Outcome Measures :
  1. Patient responding or not responding to treatment with Adalimumab at 1 year defined by a value of Disease Activity Score 28 (DAS 28) ≤ 3.2. [ Time Frame: 12 months ]
    Disease Activity Score 28 (DAS 28) calculated in every patients after clinical examination.

  2. Patient responding or not responding to treatment with Adalimumab at 6 months and 1 year defined by the SDAI scores [ Time Frame: 6 and 12 months ]
    SDAI score will be calculated in every patients after clinical examination.

  3. Patient responding or not responding to treatment with Adalimumab at 6 months and 1 year defined by the CDAI scores [ Time Frame: 6 and 12 months ]
    CDAI score will be calculated in every patients after clinical examination.

  4. Patient responding or not responding to treatment with Adalimumab at 6 months and 1 year defined by the HAQ scores [ Time Frame: 6 and 12 months ]
    HAQ will be calculated in every patients after self-assessment questionnaire.

  5. Residual plasmatic Adalimumab concentration [ Time Frame: 3, 6 and 12 months ]
  6. Count of Anti-Adalimumab antibody [ Time Frame: 3, 6 and 12 months ]
  7. Second derivative spectrometric profiles [ Time Frame: Baseline and 3 monts ]
    Serum and joint fluid



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis diagnosed according to EULAR 2010 criteria (European League Against Rheumatism);
  • Active rheumatoid arthritis, defined by DAS 28> 3.2;
  • Corticotherapy systemic ≤ 15mg /day, stable for ≥ 15 days;
  • Refractory or intolerant rheumatoid arthritis with at least one chemical background treatment;
  • Previous biological treatment stopped for ≥ 3 months for monoclonal antibodies (except Rituximab) and 15 days for Etanercept;
  • Patients who have given written informed consent.
  • For healthy volunteers: subjects aged 18 coming to the French blood establishment of Rennes for a donation of blood

Exclusion Criteria:

  • Patient minor;
  • Presence of a contraindication to biological treatment;
  • Previous treatment with Rituximab;
  • Vaccination or surgery in the month preceding the study or planned within 3 months of inclusion;
  • Patient not affiliated to social security;
  • Major persons subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
  • For healthy volunteers: Minor subject ; Subject not affiliated with social security ; Major persons subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty

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): NCT03110094


Contacts
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Contact: Aleth Perdriger +33 2 99 26 71 40 aleth.perdriger@chu-rennes.fr
Contact: Charlotte Lucas +33 2 99 26 71 40 charlotte.lucas@chu-rennes.fr

Locations
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France
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Aleth Perdriger    +33 2 99 26 71 40    aleth.perdriger@chu-rennes.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Aleth Perdriger Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03110094     History of Changes
Other Study ID Numbers: 35RC17_3063_PROMETHEE
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents