SpondylarthropathiesPhase 4REDES-TNFNCT01604629
Evaluation of a Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF
A Phase 4 study testing Reduced doses of anti-TNF and Stable doses of anti-TNF in people with Spondylarthropathies, run by Spanish Clinical Pharmacology Society at 31 sites in Spain.
Trial summary
The purpose of this study is to demonstrate that patients with Spondylarthropathies in remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylarthropathies
- What is being tested?
- Reduced doses of anti-TNF and Stable doses of anti-TNF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 31 sitesSpain
- Study dates
- Jul 2012to Sep 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years
- Patients with Spondylarthropathies according ASAS group criteria.
- Patients under treatment with anti-TNF therapy (infliximab, adalimumab, etanercept, golimumab) who present established clinical remission
- Patients to give their informed consent to participate in the study
Who cannot join
- Patients with secondary Spondylarthropathies
- Patients with Spondylarthropathies and predominantly clinical of peripheral arthritis which receive anti-TNF therapy by peripheral symp tons.
- Patients with Spondylarthropathies and other associated diseases that hinders or modify the clinical evaluation of the patient (fibromyalgia, chronic inflammatory disorders…)
- Patients with bowel inflammatory disease
- Patients under chronic therapy with anti-TNF therapy who received the patterns of reduction that will be explored in the experimental group, or low doses or most spaced that those in the experimental group before study inclusion
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Spain31 sites
Hospital Juan Canalejo
A Coruña, La Coruña
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid
Hospital Clínic Universitari Sant Joan d'Alacant
Alicante, Alacant
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Hospital Vall d'Hebron
Barcelona, Barcelona
IMIM-Hospital del Mar
Barcelona, Barcelona
Hospital Reina Sofía
Córdoba, Córdoba
Hospital Universitario de Guadalajara
Guadalajara, Guadalajara
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas
Hospital General de Llerena-Zafra
Llerena, Badajoz
Hospital Clínico San Carlos
Madrid, Madrid
Hospital General Universitario Gregorio Marañón
Madrid, Madrid
Hospital Universitario 12 de Octubre
Madrid, Madrid
Hospital Universitario de La Princesa
Madrid, Madrid
Hospital Universitario La Paz
Madrid, Madrid
Hospital Universitario Ramón y Cajal
Madrid, Madrid
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Universitario de Móstoles
Móstoles, Madrid
Hospital Universitario Virgen de la Arrixaca
Murcia, Murcia
Hospital Monte Naranco
Oviedo, Principality of Asturias
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias
Hospital Comarcal de Palamós
Palamós, Girona
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, 08208
Hospital Clínico de Salamanca
Salamanca, Salamanca
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona
Hospital Universitario Virgen Macarena
Seville, Sevilla
Hospital Sant Pau i Santa Tecla
Tarragona, Tarragona
Hospital General de Valencia
Valencia, Valencia
About this study
Official title: Evaluation of Clinical Value of Standardized Protocol for Dose-reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF Therapy: Open-label, Controlled, Randomized, Multicenter Trial.
The purpose of this study is to demonstrate that patients with Spondylarthropathies in remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule.
Read the detailed description
It has been shown that the withdrawal of treatment follows with a flare of the disease in a short time after the suspension but it has not been evaluated in controlled trials if remission could be maintained with a lower dose. A multicenter, national, open-label, randomized and controlled clinical trial of 3 years duration (2 years for inclusion + 1 year follow-up) is proposed to address this issue. The study will include 190 patients with Spondylarthropathies in stable treatment with any single anti-TNF agent and compliance with criteria of clinical remission for at least 4 months. Patients will be randomized to intervention or control arm, with stratification according to the antiTNF product thet were receiving prior to inclusion. Patients will be followed with the calendar of visits recommended by the Spanish Society of Rheumatology for clinical practice. The proposed hypothesis is of non-inferiority of the experimental arm with dose reduction versus the control arm with standard treatment.
- Conditions
- Spondylarthropathies
- Being tested
- Reduced doses of anti-TNF, Stable doses of anti-TNF
- Keywords
- Spondylarthropathies, Persistent clinical remission with anti-TNF therapy, Standardized protocol for dose reduction anti-TNF therapy
- Medical subject headings
- Spondylarthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced doses of anti-TNFDrug
Also called Adalimumab: 40 mg / 3 weeks, Etanercept: 50 mg / 10 days, Golimumab: 50 mg / 6 weeks, Infliximab: 3 mg/kg / 8 weeks
Standardized schedule of reduced doses of anti-TNF, reached either through the interval spacing of administration (adalimumab, etanercept or golimumab) or reducing doses of infliximab
Stable doses of anti-TNFDrug
Also called Adalimumab: 40 mg / 2 weeks, Etanercept: 25 mg / 3 days ó 50 mg /7 days, Golimumab: 50 mg / 4 weeks, Infliximab: 5 mg/kg / 6-8 weeks
Stable doses of anti-TNF according clinical practice based on approved summary product characteristics (SPC) and SER consensus about biological therapies in Ankylosing Spondylitis and other Spondylarthropathies, except Psoriatic Arthritis
| Study group | Role | What they receive |
|---|---|---|
| Reduced doses of anti-TNF | Experimental | Standardized schedule of reduced doses of anti-TNF, reached either through the interval spacing of administration (adalimumab, etanercept or golimumab) or reducing doses of infliximab Receives: Drug: Reduced doses of anti-TNF |
| Stable doses of anti-TNF | Active comparator | Stable doses of anti-TNF according clinical practice based on approved summary product characteristics (SPC) and SER consensus about biological therapies in Ankylosing Spondylitis and other Spondylarthropathies, except Psoriatic Arthritis Receives: Drug: Stable doses of anti-TNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Rheumatology Society (SER) consensus, after one year
Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Society of Reumatology (SER) consensus (BASDAI < 4, global clinical impression by physician <4 and by patient < 4 and axial nocturnal pain <4) after one year
Measured: one year after inclusion
Secondary outcomes (10)
Proportion of patients in remission one year after inclusion in the study
Proportion of patients in remission, defined as ASDAS-C score lower than than 1.3, after one year from inclusion in the study
Measured: one year
Proportion of patients who experience a clinical reactivation
Proportion of patients who experience a clinical reactivation, defined according criteria of active disease by Spanish Society of Reumatology (SER) consensus (BASDAI > 4, global clinical impression by physician >4 and at least one of three following criteria: patient impression >= 4, axial nocturnal pain (VAS) >= 4, and increased of acute phase reactants (reactive C protein (PCR) and/or erytrocyte sedimentation rate (ESR))
Measured: last study visit (up to 3 years or December 2014)
Proportion of patients who are kept in the acceptable therapeutic objective in the last study visit
Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Society of Reumatology (SER) consensus (BASDAI < 4, global clinical impression by physician <4 and by patient < 4 and axial nocturnal pain <4) in the last study visit
Measured: last study visit (up to 3 years or December 2014)
Proportion of patients who are kept in the ideal therapeutic objective in the last follow visit
Proportion of patients who are kept in the ideal therapeutic objective according to the Spanish Society of Reumatology (SER) consensus (BASDAI < 2, global clinical impression by physician <2 and by patient < 2 ) in the last study visit
Measured: last study visit (up to 3 years or December 2014)
Time to clinical reactivation
Time to clinical reactivation, defined according to the criteria of active disease by Spanish Society of Reumatology (SER) consensus, BASDAI + VAS and ASDAS, respectively
Measured: last study visit (up to 3 years or December 2014)
Withdrawal because of clinical requirement to modify the antiTNF treatment.
Proportion of patients who are withdrawn from the study because of clinical requirement to modify the antiTNF treatment.
Measured: last study visit (up to 3 years or December 2014)
NSAIDs use
NSAIDs use measured according semiquantitative Dougados criteria
Measured: last study visit (up to 3 years or December 2014)
Suspected Serious Adverse Reactions
Proportion of patients who experience a Serious Adverse Event at least possibly related with anti-TNF therapy.
Measured: last study visit (up to 3 years or December 2014)
Time to Suspected Serious Adverse Reaction
Time to Serious Adverse Events at least possibly related with anti-TNF therapy
Measured: last study visit (up to 3 years or December 2014)
Proportion of patients in remission after two years from inclusion in the study
Proportion of patients in remission, defined as ASDAS-C point less than 1.3, after two years from inclusion in the study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2015
- Study completionSep 2015
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 SpondylarthropathiesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Clinical Pharmacology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish reumatology Society
- Responsible party
- Principal investigator, Dra. Caridad Pontes, Spanish Clinical Pharmacology Society
- Investigators
- Gratacós Jordi, MD, PhD, Principal investigator, Hospital de Sabadell - Corporació Sanitària i Universitaria Parc Taulí UAB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604629
- Sponsor's protocol ID
- REDES-TNF/2012
- Other IDs
- 2011-005871-18
- Acronym
- REDES-TNF
- Status last verified
- Nov 2015
- First submitted
- 17 May 2012
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gratacos J, Pontes C, Juanola X, Sanz J, Torres F, Avendano C, Vallano A, Calvo G, de Miguel E, Sanmarti R; REDES-TNF investigators. Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis. Arthritis Res Ther. 2019 Jan 8;21(1):11. doi: 10.1186/s13075-018-1772-z.
PubMed 30621746
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Value of Standardized Protocol for Dose-reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF Therapy: Open-label, Controlled, Randomized, Multicenter Trial.
- ClinicalTrials.gov ID
- NCT01604629
- Acronym / sponsor ID
- REDES-TNF / REDES-TNF/2012
- Conditions
- Spondylarthropathies
- Keywords
- Spondylarthropathies, Persistent clinical remission with anti-TNF therapy, Standardized protocol for dose reduction anti-TNF therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Spanish Clinical Pharmacology SocietyUniversity, hospital or other
- Collaborators
- Spanish reumatology Society
- Study start
- Jul 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 May 2012 (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 purpose of this study is to demonstrate that patients with Spondylarthropathies in remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule.
Detailed description
It has been shown that the withdrawal of treatment follows with a flare of the disease in a short time after the suspension but it has not been evaluated in controlled trials if remission could be maintained with a lower dose. A multicenter, national, open-label, randomized and controlled clinical trial of 3 years duration (2 years for inclusion + 1 year follow-up) is proposed to address this issue. The study will include 190 patients with Spondylarthropathies in stable treatment with any single anti-TNF agent and compliance with criteria of clinical remission for at least 4 months. Patients will be randomized to intervention or control arm, with stratification according to the antiTNF product thet were receiving prior to inclusion. Patients will be followed with the calendar of visits recommended by the Spanish Society of Rheumatology for clinical practice. The proposed hypothesis is of non-inferiority of the experimental arm with dose reduction versus the control arm with standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced doses of anti-TNF | Experimental | Drug: Reduced doses of anti-TNFStandardized schedule of reduced doses of anti-TNF, reached either through the interval spacing of administration (adalimumab, etanercept or golimumab) or reducing doses of infliximab |
| Stable doses of anti-TNF | Active comparator | Drug: Stable doses of anti-TNFStable doses of anti-TNF according clinical practice based on approved summary product characteristics (SPC) and SER consensus about biological therapies in Ankylosing Spondylitis and other Spondylarthropathies, except Psoriatic Arthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years
- Patients with Spondylarthropathies according ASAS group criteria.
- Patients under treatment with anti-TNF therapy (infliximab, adalimumab, etanercept, golimumab) who present established clinical remission
- Patients to give their informed consent to participate in the study
Key exclusion criteria (5 listed)
- Patients with secondary Spondylarthropathies
- Patients with Spondylarthropathies and predominantly clinical of peripheral arthritis which receive anti-TNF therapy by peripheral symp tons.
- Patients with Spondylarthropathies and other associated diseases that hinders or modify the clinical evaluation of the patient (fibromyalgia, chronic inflammatory disorders…)
- Patients with bowel inflammatory disease
- Patients under chronic therapy with anti-TNF therapy who received the patterns of reduction that will be explored in the experimental group, or low doses or most spaced that those in the experimental group before study inclusion
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 |
|---|---|---|
| Reduced doses of anti-TNFAlso: Adalimumab: 40 mg / 3 weeks, Etanercept: 50 mg / 10 days, Golimumab: 50 mg / 6 weeks, Infliximab: 3 mg/kg / 8 weeksStandardized schedule of reduced doses of anti-TNF, reached either through the interval spacing of administration (adalimumab, etanercept or golimumab) or reducing doses of infliximab | Drug | Reduced doses of anti-TNF |
| Stable doses of anti-TNFAlso: Adalimumab: 40 mg / 2 weeks, Etanercept: 25 mg / 3 days ó 50 mg /7 days, Golimumab: 50 mg / 4 weeks, Infliximab: 5 mg/kg / 6-8 weeksStable doses of anti-TNF according clinical practice based on approved summary product characteristics (SPC) and SER consensus about biological therapies in Ankylosing Spondylitis and other Spondylarthropathies, except Psoriatic Arthritis | Drug | Stable doses of anti-TNF |
Primary outcome
Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Rheumatology Society (SER) consensus, after one year
Time frame: one year after inclusion
Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Society of Reumatology (SER) consensus (BASDAI < 4, global clinical impression by physician <4 and by patient < 4 and axial nocturnal pain <4) after one year
10 secondary outcomes
Proportion of patients in remission one year after inclusion in the study
Time frame: one year
Proportion of patients who experience a clinical reactivation
Time frame: last study visit (up to 3 years or December 2014)
Proportion of patients who are kept in the acceptable therapeutic objective in the last study visit
Time frame: last study visit (up to 3 years or December 2014)
Proportion of patients who are kept in the ideal therapeutic objective in the last follow visit
Time frame: last study visit (up to 3 years or December 2014)
Time to clinical reactivation
Time frame: last study visit (up to 3 years or December 2014)
Withdrawal because of clinical requirement to modify the antiTNF treatment.
Time frame: last study visit (up to 3 years or December 2014)
NSAIDs use
Time frame: last study visit (up to 3 years or December 2014)
Suspected Serious Adverse Reactions
Time frame: last study visit (up to 3 years or December 2014)
Time to Suspected Serious Adverse Reaction
Time frame: last study visit (up to 3 years or December 2014)
Proportion of patients in remission after two years from inclusion in the study
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
- Derived from this study: PubMed 30621746Gratacos J, Pontes C, Juanola X, Sanz J, Torres F, Avendano C, Vallano A, Calvo G, de Miguel E, Sanmarti R; REDES-TNF investigators. Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis. Arthritis Res Ther. 2019 Jan 8;21(1):11. doi: 10.1186/s13075-018-1772-z.
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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.
Gratacós Jordi, MD, PhD principal investigator
Hospital de Sabadell - Corporació Sanitària i Universitaria Parc Taulí UAB
31 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 Reduced doses of anti-TNF and Stable doses of anti-TNF in people with Spondylarthropathies, run by Spanish Clinical Pharmacology Society at 31 sites in Spain.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Rheumatology Society (SER) consensus, after one year (time frame: one year 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 NCT01604629, 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 17 Nov 2015.