Evaluation of a Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF (REDES-TNF)
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ClinicalTrials.gov Identifier: NCT01604629 |
Recruitment Status :
Completed
First Posted : May 24, 2012
Last Update Posted : November 17, 2015
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Condition or disease | Intervention/treatment | Phase |
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Spondylarthropathies | Drug: Reduced doses of anti-TNF Drug: Stable doses of anti-TNF | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
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Experimental: Reduced doses of anti-TNF
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
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Drug: Reduced doses of anti-TNF
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
Other Names:
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Active Comparator: Stable doses of anti-TNF
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
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Drug: Stable doses of anti-TNF
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
Other Names:
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- 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
- Proportion of patients in remission one year after inclusion in the study [ Time Frame: one year ]Proportion of patients in remission, defined as ASDAS-C score lower than than 1.3, after one year from inclusion in the study
- Proportion of patients who experience a clinical reactivation [ Time Frame: last study visit (up to 3 years or December 2014) ]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))
- 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 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
- 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) ]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
- Time to clinical reactivation [ Time Frame: last study visit (up to 3 years or December 2014) ]Time to clinical reactivation, defined according to the criteria of active disease by Spanish Society of Reumatology (SER) consensus, BASDAI + VAS and ASDAS, respectively
- Withdrawal because of clinical requirement to modify the antiTNF treatment. [ Time Frame: last study visit (up to 3 years or December 2014) ]Proportion of patients who are withdrawn from the study because of clinical requirement to modify the antiTNF treatment.
- NSAIDs use [ Time Frame: last study visit (up to 3 years or December 2014) ]NSAIDs use measured according semiquantitative Dougados criteria
- Suspected Serious Adverse Reactions [ Time Frame: last study visit (up to 3 years or December 2014) ]Proportion of patients who experience a Serious Adverse Event at least possibly related with anti-TNF therapy.
- Time to Suspected Serious Adverse Reaction [ Time Frame: last study visit (up to 3 years or December 2014) ]Time to Serious Adverse Events at least possibly related with anti-TNF therapy
- Proportion of patients in remission after two years from inclusion in the study [ Time Frame: 2 years ]Proportion of patients in remission, defined as ASDAS-C point less than 1.3, after two years from inclusion in the study

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604629

Principal Investigator: | Gratacós Jordi, MD, PhD | Hospital de Sabadell - Corporació Sanitària i Universitaria Parc Taulí UAB |
Responsible Party: | Dra. Caridad Pontes, Study coordinator, Spanish Clinical Pharmacology Society |
ClinicalTrials.gov Identifier: | NCT01604629 |
Other Study ID Numbers: |
REDES-TNF/2012 2011-005871-18 ( EudraCT Number ) |
First Posted: | May 24, 2012 Key Record Dates |
Last Update Posted: | November 17, 2015 |
Last Verified: | November 2015 |
Spondylarthropathies Persistent clinical remission with anti-TNF therapy Standardized protocol for dose reduction anti-TNF therapy |
Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Musculoskeletal Diseases Arthritis Joint Diseases Adalimumab Etanercept Infliximab Antibodies, Monoclonal |
Anti-Inflammatory Agents Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors Dermatologic Agents |