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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005871-18 | EudraCT Number |
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| Name | Class |
|---|---|
| Spanish reumatology Society | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced doses of anti-TNF | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one year after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one year |
| Proportion of patients who experience a clinical reactivation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gratacós Jordi, MD, PhD | Hospital de Sabadell - Corporació Sanitària i Universitaria Parc Taulí UAB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic Universitari Sant Joan d'Alacant | Alicante | Alacant | Spain | |||
| Hospital General de Llerena-Zafra |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30621746 | Derived | 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. |
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|
| Stable doses of anti-TNF | Drug | 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 |
|
|
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)) |
| 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 | 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 | 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 | 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. | last study visit (up to 3 years or December 2014) |
| NSAIDs use | NSAIDs use measured according semiquantitative Dougados criteria | 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. | 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 | 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 | 2 years |
| Llerena |
| Badajoz |
| Spain |
| Hospital Son Llàtzer | Palma de Mallorca | Balearic Islands | Spain |
| Hospital Clínic de Barcelona | Barcelona | Barcelona | 08036 | Spain |
| Hospital Vall d'Hebron | Barcelona | Barcelona | Spain |
| IMIM-Hospital del Mar | Barcelona | Barcelona | Spain |
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Corporació Sanitària Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| Hospital de Sant Joan Despí Moisès Broggi | Sant Joan Despí | Barcelona | Spain |
| Hospital Reina Sofía | Córdoba | Córdoba | Spain |
| Hospital Comarcal de Palamós | Palamós | Girona | Spain |
| Hospital Universitario de Guadalajara | Guadalajara | Guadalajara | Spain |
| Hospital Juan Canalejo | A Coruña | La Coruña | Spain |
| Hospital Universitario de Gran Canaria Dr. Negrín | Las Palmas de Gran Canaria | Las Palmas | Spain |
| Hospital Universitario Príncipe de Asturias | Alcalá de Henares | Madrid | Spain |
| Hospital Universitario Fundación Alcorcón | Alcorcón | Madrid | Spain |
| Hospital Clínico San Carlos | Madrid | Madrid | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | Spain |
| Hospital Universitario de La Princesa | Madrid | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario de Móstoles | Móstoles | Madrid | Spain |
| Hospital Universitario Virgen de la Arrixaca | Murcia | Murcia | Spain |
| Hospital Monte Naranco | Oviedo | Principality of Asturias | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | Spain |
| Hospital Clínico de Salamanca | Salamanca | Salamanca | Spain |
| Hospital Universitario Virgen Macarena | Seville | Sevilla | Spain |
| Hospital Sant Pau i Santa Tecla | Tarragona | Tarragona | Spain |
| Hospital General de Valencia | Valencia | Valencia | Spain |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D000068800 | Etanercept |
| C529000 | golimumab |
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D007127 | Immunoglobulin Constant Regions |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
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