Rheumatoid ArthritisSTRATEGE2NCT05082805
Therapeutic Strategy Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Nordic Pharma SAS at 1 site in France.
Trial summary
This is a longitudinal, observational, prospective, multicentre study conducted in France, among a representative sample of rheumatology doctors. The aim of this study is to describe in real life the therapeutic strategy when faced with a patient with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) who requires… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RA or PsA patient undergoing treatment with MTX for at least 3 months and requiring the introduction of a first bDMARD or tsDMARD due to the activity of the disease will be asked to participate from bDMARD or tsDMARD treatment introduction (inclusion visit) up to 24 months after inclusion.
Who may be able to join
- Major patient (age ≥ 18 years)
- Patient with RA according to American College of Rheumatology (ACR) / European Congress of Rheumatology (EULAR) 2010 or ACR 1987 or patient with PsA according to ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria
- Patient undergoing treatment with methotrexate (MTX) (oral or injectable) initiated for at least 3 months.
- Naïve patient of biotherapy or tsDMARD and requiring the introduction of a first bDMARD or tsDMARD due to the activity of the disease.
- Patient informed and accepting the computer processing of his/her medical data and informed of his/her rights of access and rectification.
Who cannot join
- Patient participating in an interventional study in rheumatology
- Patient with axial spondyloarthritis (for patients with PsA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Strategy Concerning the Drug Management Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis
This is a longitudinal, observational, prospective, multicentre study conducted in France, among a representative sample of rheumatology doctors.
The aim of this study is to describe in real life the therapeutic strategy when faced with a patient with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) who requires initiation of treatment with biotherapy or targeted therapy. The evolution of the disease and the possible therapeutic adaptations will then be followed for 2 years.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure is not provided for now to the investigators (and public) in order not to bias the therapeutic strategies.
Not provided as Outcome 1 is blinded
Measured: 12 months after inclusion
Secondary outcomes (8)
Main criteria analysis
Same Outcome 1, but at 24 month. This outcome is blinded too.
Measured: 24 months after inclusion
Therapeutic adaptations of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), targeted synthetic DMARDs (tsDMARDs), Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids
delays, changes in dosage, changes in the route of administration, reasons for adaptations ...
Measured: 12 and 24 months after inclusion
Disease outcome
disease activity (Disease Activity Score DAS28 and Disease Activity in PSoriatic Arthritis DAPSA)), percentage of patients in remission, quality of Life (Dermatology Life Quality Index (DLQI))
Measured: 12 and 24 months after inclusion
Patient adherence to treatment
The variation of patients' adherence to antirheumatic treatments evaluated by the Compliance Questionnaire for Rhumatology (CQR19).
Measured: 12 and 24 months after inclusion
Fatigue and pain
Visual Analog Scale (VAS) anchored by 2 verbal descriptors, one for each symptom extreme : 0 (no fatigue, no pain) to 10 (maximum fatigue, maximum pain).
Measured: 12 and 24 months after inclusion
Functional capacity (Health Assessment Questionnaire (HAQ))
This questionnaire is completed by patients at baseline, 12 months and 24 months.
Measured: 12 and 24 months after inclusion
Cross-perception (doctor / patient) about participation in the "shared medical decision"
This outcome is based on 2 mirror questions (one asked to the physician and on to the patient). They are asked if the decision to adapt the therapeutic decision is a "shared medical decision". Five answers are possible from "fully" to "not at all".
Measured: 12 and 24 months after inclusion
Care path at the end of the visit
The physician is asked about the patient pathway (How and by whom the patient will be followed : nurse, other physicians)
Measured: 12 and 24 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start25 Feb 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordic Pharma SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hélène HERMAN-DEMARS, MD, Study director, Nordic PharmaRené Marc FLIPO, Prof, Principal investigator, CHRU LILLECécile GAUJOUX-VIALA, Dr, Principal investigator, CHU NîmesEmmanuelle DERNIS, Dr, Principal investigator, CH Le MansÉric SENBEL, Dr, Principal investigator, Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082805
- Sponsor's protocol ID
- STRATEGE 2
- Acronym
- STRATEGE2
- Status last verified
- Oct 2021
- First submitted
- 24 Jun 2019
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaujoux-Viala C, Dernis E, Senbel E, Herman-Demars H, Becker J, Flipo RM. Methotrexate Maintenance After Initiation of Biological or Targeted Synthetic DMARDs in Rheumatoid Arthritis: Results from the 2-Year Longitudinal Prospective Non-interventional STRATEGE2 Study. Rheumatol Ther. 2026 Feb;13(1):157-177. doi: 10.1007/s40744-025-00806-1. Epub 2025 Dec 3.
PubMed 41335306
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Strategy Concerning the Drug Management Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT05082805
- Acronym / sponsor ID
- STRATEGE2 / STRATEGE 2
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nordic Pharma SASIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a longitudinal, observational, prospective, multicentre study conducted in France, among a representative sample of rheumatology doctors.
The aim of this study is to describe in real life the therapeutic strategy when faced with a patient with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) who requires initiation of treatment with biotherapy or targeted therapy. The evolution of the disease and the possible therapeutic adaptations will then be followed for 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA or PsA patient undergoing treatment with MTX for at least 3 months and requiring the introduction of a first bDMARD or tsDMARD due to the activity of the disease will be asked to participate from bDMARD or tsDMARD treatment introduction (inclusion visit) up to 24 months after inclusion.
Key inclusion criteria (5 listed)
- Major patient (age ≥ 18 years)
- Patient with RA according to American College of Rheumatology (ACR) / European Congress of Rheumatology (EULAR) 2010 or ACR 1987 or patient with PsA according to ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria
- Patient undergoing treatment with methotrexate (MTX) (oral or injectable) initiated for at least 3 months.
- Naïve patient of biotherapy or tsDMARD and requiring the introduction of a first bDMARD or tsDMARD due to the activity of the disease.
- Patient informed and accepting the computer processing of his/her medical data and informed of his/her rights of access and rectification.
Key exclusion criteria (2 listed)
- Patient participating in an interventional study in rheumatology
- Patient with axial spondyloarthritis (for patients with PsA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Primary Outcome Measure is not provided for now to the investigators (and public) in order not to bias the therapeutic strategies.
Time frame: 12 months after inclusion
Not provided as Outcome 1 is blinded
8 secondary outcomes
Main criteria analysis
Time frame: 24 months after inclusion
Therapeutic adaptations of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), targeted synthetic DMARDs (tsDMARDs), Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids
Time frame: 12 and 24 months after inclusion
Disease outcome
Time frame: 12 and 24 months after inclusion
Patient adherence to treatment
Time frame: 12 and 24 months after inclusion
Fatigue and pain
Time frame: 12 and 24 months after inclusion
Functional capacity (Health Assessment Questionnaire (HAQ))
Time frame: 12 and 24 months after inclusion
Cross-perception (doctor / patient) about participation in the "shared medical decision"
Time frame: 12 and 24 months after inclusion
Care path at the end of the visit
Time frame: 12 and 24 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Derived from this study: PubMed 41335306Gaujoux-Viala C, Dernis E, Senbel E, Herman-Demars H, Becker J, Flipo RM. Methotrexate Maintenance After Initiation of Biological or Targeted Synthetic DMARDs in Rheumatoid Arthritis: Results from the 2-Year Longitudinal Prospective Non-interventional STRATEGE2 Study. Rheumatol Ther. 2026 Feb;13(1):157-177. doi: 10.1007/s40744-025-00806-1. Epub 2025 Dec 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène HERMAN-DEMARS, MD study director
Nordic Pharma
René Marc FLIPO, Prof principal investigator
CHRU LILLE
Cécile GAUJOUX-VIALA, Dr principal investigator
CHU Nîmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Nordic Pharma SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Outcome Measure is not provided for now to the investigators (and public) in order not to bias the therapeutic strategies. (time frame: 12 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05082805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.