SpondyloarthritisPhase 4STRADANCT01971918
Comparative Analysis of Two Therapeutic Strategies in Patients With Spondyloarthritis Treated With Anti-tnf Biologics
A Phase 4 study testing anti drug antibodies dosage in people with Spondyloarthritis, run by University Hospital, Rouen at 7 sites in France.
Trial summary
The objective of the study is to evaluate two therapeutic strategies: "early switch" or "therapeutic intensification" in patients with spondyloarthritis in case of secondary treatment failure suspicion to a first monoclonal antibodies anti-TNF definite by increase of ASDAS and positivity to ADAb. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- anti drug antibodies dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 7 sitesFrance
- Study dates
- May 2014to Apr 2017
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spondyloarthritis positive for the ASAS criteria, treated with a first biologic : infliximab ( 5mg/kg intravenously every 8 weeks) or adalimumab (40mg subcutaneously every 2 weeks)
- Active spondyloarthritis definite by ASDAS-CRP > 2.1 at two successive evaluations while patient was previously responder (ASDAS<2.1 at least once in the 6th months after beginning of treatment)
- Positivity to anti-drug antibodies (ADAb)
- Consent of the patient
- No contra-indication to another anti-tnf biologic
- affiliation to health insurance
- woman of childbearing age must use an appropriate mean of contraception
Who cannot join
- Pregnant or breastfeeding woman
- contra-indication to anti-tnf biologic
- patient with known hypersensitivity to any of the excipients
- Severe and uncontrolled opportunistic infection , includins septicemia, tuberculosis, abcess and opportunistic infection
- Evolutive infection, including chronic or localised infection
- Patient with moderate to severe heart failure (NYHA class III/IV)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
UH Amiens
Amiens, 60
UH Caen
Caen, 14000
Dieppe Hospital
Dieppe, 76202
Elbeuf Hospital
Elbeuf, 76410
UH Lille
Lille, 59000
Le Havre Hospital
Montivilliers, 76290
UH Rouen
Rouen, 76031
About this study
Official title: Comparative Analysis of Two Therapeutic Strategies: "Early Switch" Versus "Therapeutic Intensification" in Patients With Spondyloarthritis Treated With Anti-tnf Biologics, in Case of Secondary Treatment Failure Suspicion.
The objective of the study is to evaluate two therapeutic strategies: "early switch" or "therapeutic intensification" in patients with spondyloarthritis in case of secondary treatment failure suspicion to a first monoclonal antibodies anti-TNF definite by increase of ASDAS and positivity to ADAb.
Patients and Methods:
Read more
Multicentric randomized prospective study. Duration of inclusion 30 months. Duration of follow-up 24 months. 104 patients with spondyloarthritis treated with infliximab or adalimumab will be included if their ADAb dosage is positive, and they will be randomized (1:1) in two groups : "early switch" where treatment will be change to another anti-TNF, or "therapeutic intensification" where interval between two injections will be shortened. Patients will be evaluated clinically (ASDAS) and biologically (ADAb) at 12 weeks then at 24 weeks. Principal outcome will be the variation of ASDAS between baseline and end of the study. Number of patients to be included has been determined statistically from a preliminary study (power >98% for ASDAS variation of 20% on week 24).
Expected results:
On week 24, we expect a better response and a greater proportion of patients in remission in the "early switch" arm compare to the "therapeutic intensification" arm.
- Conditions
- Spondyloarthritis
- Being tested
- anti drug antibodies dosage
- Keywords
- spondyloarthritis, monoclonal antibodies anti-TNF, secondary treatment failure
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti drug antibodies dosageBiological
anti drug antibodies dosage
| Study group | Role | What they receive |
|---|---|---|
| early switch | Experimental | * early switch of monoclonal antibodies anti-TNF
* anti drug antibodies dosage Receives: Biological: anti drug antibodies dosage |
| therapeutic intensification | Experimental | * therapeutic intensification of monoclonal antibodies anti-TNF
* anti drug antibodies dosage Receives: Biological: anti drug antibodies dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of ASDAS between inclusion and 24 weeks of treatment
ASDAS will be measured at week 24 and will be compared to day 1
Measured: Week 24
Secondary outcomes (1)
Frequency of patients with ASDAS < 2.1
Frequency of patients with ASDAS < 2.1 at week 24 ASDAS < 2.1 is considered as remission
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startMay 2014
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier VITTECOQ, Prof, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971918
- Sponsor's protocol ID
- 2013/006/HP
- Acronym
- STRADA
- Status last verified
- Jun 2017
- First submitted
- 11 Oct 2013
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Two Therapeutic Strategies: "Early Switch" Versus "Therapeutic Intensification" in Patients With Spondyloarthritis Treated With Anti-tnf Biologics, in Case of Secondary Treatment Failure Suspicion.
- ClinicalTrials.gov ID
- NCT01971918
- Acronym / sponsor ID
- STRADA / 2013/006/HP
- Conditions
- Spondyloarthritis
- Keywords
- spondyloarthritis, monoclonal antibodies anti-TNF, secondary treatment failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 29 Oct 2013 (estimated)
- 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.
The objective of the study is to evaluate two therapeutic strategies: "early switch" or "therapeutic intensification" in patients with spondyloarthritis in case of secondary treatment failure suspicion to a first monoclonal antibodies anti-TNF definite by increase of ASDAS and positivity to ADAb.
Patients and Methods:
Multicentric randomized prospective study. Duration of inclusion 30 months. Duration of follow-up 24 months. 104 patients with spondyloarthritis treated with infliximab or adalimumab will be included if their ADAb dosage is positive, and they will be randomized (1:1) in two groups : "early switch" where treatment will be change to another anti-TNF, or "therapeutic intensification" where interval between two injections will be shortened. Patients will be evaluated clinically (ASDAS) and biologically (ADAb) at 12 weeks then at 24 weeks. Principal outcome will be the variation of ASDAS between baseline and end of the study. Number of patients to be included has been determined statistically from a preliminary study (power >98% for ASDAS variation of 20% on week 24).
Expected results:
On week 24, we expect a better response and a greater proportion of patients in remission in the "early switch" arm compare to the "therapeutic intensification" arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early switch | Experimental | Biological: anti drug antibodies dosage* early switch of monoclonal antibodies anti-TNF * anti drug antibodies dosage |
| therapeutic intensification | Experimental | Biological: anti drug antibodies dosage* therapeutic intensification of monoclonal antibodies anti-TNF * anti drug antibodies dosage |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Spondyloarthritis positive for the ASAS criteria, treated with a first biologic : infliximab ( 5mg/kg intravenously every 8 weeks) or adalimumab (40mg subcutaneously every 2 weeks)
- Active spondyloarthritis definite by ASDAS-CRP > 2.1 at two successive evaluations while patient was previously responder (ASDAS<2.1 at least once in the 6th months after beginning of treatment)
- Positivity to anti-drug antibodies (ADAb)
- Consent of the patient
- No contra-indication to another anti-tnf biologic
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding woman
- contra-indication to anti-tnf biologic
- patient with known hypersensitivity to any of the excipients
- Severe and uncontrolled opportunistic infection , includins septicemia, tuberculosis, abcess and opportunistic infection
- Evolutive infection, including chronic or localised infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti drug antibodies dosageanti drug antibodies dosage | Biological | early switch, therapeutic intensification |
Primary outcome
Variation of ASDAS between inclusion and 24 weeks of treatment
Time frame: Week 24
ASDAS will be measured at week 24 and will be compared to day 1
1 secondary outcome
Frequency of patients with ASDAS < 2.1
Time frame: Week 24
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
Related trials for Spondyloarthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Olivier VITTECOQ, Prof principal investigator
UH Rouen
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing anti drug antibodies dosage in people with Spondyloarthritis, run by University Hospital, Rouen at 7 sites 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of recruitment). 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?
Variation of ASDAS between inclusion and 24 weeks of treatment (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2017.