NCT03110094

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

March 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2020

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

2.8 years

First QC Date

March 10, 2017

Last Update Submit

January 5, 2023

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (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.

    Disease Activity Score 28 (DAS 28) calculated in every patients after clinical examination.

    6 months

Secondary Outcomes (7)

  • 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.

    12 months

  • Patient responding or not responding to treatment with Adalimumab at 6 months and 1 year defined by the SDAI scores

    6 and 12 months

  • Patient responding or not responding to treatment with Adalimumab at 6 months and 1 year defined by the CDAI scores

    6 and 12 months

  • Patient responding or not responding to treatment with Adalimumab at 6 months and 1 year defined by the HAQ scores

    6 and 12 months

  • Residual plasmatic Adalimumab concentration

    3, 6 and 12 months

  • +2 more secondary outcomes

Study Arms (2)

Rheumatoid arthritis - Adalimumab

OTHER
Other: Adalimumab

Healthy volunteer

OTHER
Other: Healthy volunteers

Interventions

AdalimumabOTHER

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).

Also known as: Additional Biological Sample
Rheumatoid arthritis - Adalimumab
Healthy volunteersOTHER

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.

Also known as: Recovery of blood tubes during a donation
Healthy volunteer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient minor;
  • Presence of a contraindication to biological treatment;
  • Previous treatment with Rituximab;
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Aleth Perdriger

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2017

First Posted

April 12, 2017

Study Start

March 13, 2017

Primary Completion

January 13, 2020

Study Completion

January 13, 2020

Last Updated

January 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)