Psoriasis VulgarisNCT01753245
Analysis Of The Influence Of Metabolic Syndrome On Treatment Efficacy With Anti-Tnf In Moderate-Severe Psoriasis In Real Clinical Practice.
An observational study of Psoriasis Vulgaris and Metabolic Syndrome, run by Juan Ruano at 1 site in Spain.
Trial summary
It has been reported in various epidemiological studies that patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, have an increased frequency of cardiovascular risk factors, such as hypertension, obesity, type-2 diabetes mellitus (T2DM, and metabolic syndrome (MetS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriasis Vulgaris, Metabolic Syndrome
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2012to Jun 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: -Moderate-to-severe psoriasis treated >1 ys with anti-TNFalpha drugs at Reina Sofia University Hospital
Who may be able to join
- Moderate-to-severe psoriasis treated >1 ys with anti-TNFalpha drugs
- Age >18 ys/<80 ys
- With or without psoriatic arthritis
Who cannot join
- Enrolled in another trial
- Lack of clinical information
- Pregnant
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Dermatology. Reina Sofia University Hospital.
Córdoba, Cordoba, 14004
About this study
Official title: CARDIOVASCULAR RISK FACTORS IN A SPANISH POPULATION OF PATIENTS WITH MODERATE-TO-SEVERE PSORIASIS VULGARIS, WITH OR WITHOUT ARTHRITIS, TREATED WITH ANTI-TNF IN REAL CLINICAL PRACTICE. ANALYSIS OF THE INFLUENCE OF METABOLIC SYNDROME ON TREATMENT EFFICACY.
It has been reported in various epidemiological studies that patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, have an increased frequency of cardiovascular risk factors, such as hypertension, obesity, type-2 diabetes mellitus (T2DM, and metabolic syndrome (MetS). The presence of endothelial dysfunction in early stages, especially in moderate-to-severe plaque psoriasis forms, could explain the higher prevalence of cardiovascular disease and mortality observed in this population. Existing evidence showing improvement in psoriasis after correcting some factors, such as obesity or hypercholesterolemia, and the reduction of certain surrogate markers of cardiovascular risk with different modalities of psoriasis treatment suggest a biological interaction between the two diseases beyond mere epidemiological association. Recently published results support this hypothesis and suggest that the link between psoriasis and cardiovascular disease could be the existence of an inflammatory state in different organs, including skin, joints, adipose and hepatic tissue, and vascular endothelium (16). Patients with MetS have an increased risk of developing T2DM and cardiovascular disease. This syndrome is characterized by the association of an adipose tissue inflammatory state and diminished sensitivity to insulin. In recent years, a new mechanism participating in the development of MetS has been added: the Wnt signaling pathway. Polymorphisms in genes of the Wnt signaling pathway have been associated with metabolic abnormalities that predispose to cardiovascular disease, the development of moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, and response to treatment with anti-TNF-alpha.
This study aims to describe the cardiovascular risk factors of a Spanish population of patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis,treated with anti-TNF under routine clinical practice conditions. Possible differences in efficacy relative to the presence or absence of criteria of metabolic syndrome will be analyzed. Similarly, we will explore the role of markers of inflammatory activity and genetic polymorphisms in the Wnt pathway in predicting response to treatment during the first year.
Read the detailed description
- Eligibility criteria: 1.1. Inclusion criteria:
- -Age >18 ys.
- -Male and female.
- -Moderate-to-severe psoriasis vulgaris, with or without psoriatic arthritis.
- -Treated with anti-TNF drugs (infliximab, etanercept, adalimumab). 1.2. Exclusion criteria: <!-- -->
- -Enrolled in another clinical trial.
- -Lack of clinical information at the hospital database.
- Objectives:
2.1. Primary objective: Evaluate the efficacy of anti-TNF- drugs in the treatment of patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, in terms of the presence or absence of cardiovascular risk factors, including metabolic syndrome.
2.2. Secondary objectives:
- 2.2.1. Analyze the possible modulatory role of genetic factors, such as Wnt pathway's gene polymorphisms, and other nongenetic factors on responsiveness to treatment with anti-TNF drugs in the overall study population and in the subgroup of patients with metabolic syndrome.
- 2.2.2. Describe the cardiovascular risk factors in patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, treated with anti-TNF- in the Spanish population under routine clinical practice conditions.
- Conditions
- Psoriasis Vulgaris, Metabolic Syndrome
- Keywords
- Anti-TNF drugs efficacy, Moderate-to-severe psoriasis vulgaris, Gene polymorphism
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-Metabolic Syndrome | Patients without Metabolic Syndrome criteria (OMS). | |
| Metabolic Syndrome | Patients with Metabolic Syndrome criteria (OMS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of Metabolic Syndrome on anti-TNF-drug efficacy.
Evaluate the efficacy of anti-TNF-drugs in themoderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, in terms of the presence or absence of cardiovascular risk factors, including metabolic syndrome.
Measured: After one year of treatment
Secondary outcomes (1)
Effect of 'Wnt pathway' genetic polymorphisms on anti-TNF-drug efficacy
Analyze the possible modulatory role of genetic factors, such as Wnt polymorphisms, and nongenetic factors on responsiveness to treatment with anti-TNF drugs in the overall study population and in the subgroup of patients with metabolic syndrome.
Measured: First year of treament
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies 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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Ruano
- Sponsor type
- Other government
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, Juan Ruano, Hospital Universitario Reina Sofia de Cordoba
- Investigators
- Juan Ruano, M.D., Ph.D., Ms. C., Principal investigator, Departament of Dermatology. Reina Sofia University Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753245
- Sponsor's protocol ID
- JRR-ANT-2012-01
- Other IDs
- JRR-ANT-2012-01
- Status last verified
- Mar 2014
- First submitted
- 17 Dec 2012
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gisondi P, Farina S, Giordano MV, Girolomoni G. Usefulness of the framingham risk score in patients with chronic psoriasis. Am J Cardiol. 2010 Dec 15;106(12):1754-7. doi: 10.1016/j.amjcard.2010.08.016. Epub 2010 Nov 4.
PubMed 21055711Choi WJ, Park EJ, Kwon IH, Kim KH, Kim KJ. Association between Psoriasis and Cardiovascular Risk Factors in Korean Patients. Ann Dermatol. 2010 Aug;22(3):300-6. doi: 10.5021/ad.2010.22.3.300. Epub 2010 Aug 5.
PubMed 20711266Limbrock GJ, Hoyer H, Scheying H. Drooling, chewing and swallowing dysfunctions in children with cerebral palsy: treatment according to Castillo-Morales. ASDC J Dent Child. 1990 Nov-Dec;57(6):445-51.
PubMed 2147927Karadag AS, Yavuz B, Ertugrul DT, Akin KO, Yalcin AA, Deveci OS, Ata N, Kucukazman M, Dal K. Is psoriasis a pre-atherosclerotic disease? Increased insulin resistance and impaired endothelial function in patients with psoriasis. Int J Dermatol. 2010 Jun;49(6):642-6. doi: 10.1111/j.1365-4632.2009.04358.x.
PubMed 20618468Prey S, Paul C, Bronsard V, Puzenat E, Gourraud PA, Aractingi S, Aubin F, Bagot M, Cribier B, Joly P, Jullien D, Le Maitre M, Richard-Lallemand MA, Ortonne JP. Cardiovascular risk factors in patients with plaque psoriasis: a systematic review of epidemiological studies. J Eur Acad Dermatol Venereol. 2010 Apr;24 Suppl 2:23-30. doi: 10.1111/j.1468-3083.2009.03564.x.
PubMed 20443997Zindanci I, Albayrak O, Kavala M, Kocaturk E, Can B, Sudogan S, Koc M. Prevalence of metabolic syndrome in patients with psoriasis. ScientificWorldJournal. 2012;2012:312463. doi: 10.1100/2012/312463. Epub 2012 Apr 24.
PubMed 22654590Alsufyani MA, Golant AK, Lebwohl M. Psoriasis and the metabolic syndrome. Dermatol Ther. 2010 Mar-Apr;23(2):137-43. doi: 10.1111/j.1529-8019.2010.01307.x.
PubMed 20415820Martyn-Simmons CL, Ranawaka RR, Chowienczyk P, Crook MA, Marber MS, Smith CH, Barker JN. A prospective case-controlled cohort study of endothelial function in patients with moderate to severe psoriasis. Br J Dermatol. 2011 Jan;164(1):26-32. doi: 10.1111/j.1365-2133.2010.10031.x. Epub 2010 Nov 8.
PubMed 20819085Ardic I, Kaya MG, Yarlioglues M, Karadag Z, Dogan A, Yildiz H, Dogdu O, Zencir C, Aktas E, Ergin A. Impaired aortic elastic properties in normotensive patients with psoriasis. Blood Press. 2010 Dec;19(6):351-8. doi: 10.3109/08037051.2010.505322. Epub 2010 Jul 16.
PubMed 20635857Abuabara K, Azfar RS, Shin DB, Neimann AL, Troxel AB, Gelfand JM. Cause-specific mortality in patients with severe psoriasis: a population-based cohort study in the U.K. Br J Dermatol. 2010 Sep;163(3):586-92. doi: 10.1111/j.1365-2133.2010.09941.x.
PubMed 20633008Gisondi P, Del Giglio M, Di Francesco V, Zamboni M, Girolomoni G. Weight loss improves the response of obese patients with moderate-to-severe chronic plaque psoriasis to low-dose cyclosporine therapy: a randomized, controlled, investigator-blinded clinical trial. Am J Clin Nutr. 2008 Nov;88(5):1242-7. doi: 10.3945/ajcn.2008.26427.
PubMed 18996858Ghazizadeh R, Tosa M, Ghazizadeh M. Clinical improvement in psoriasis with treatment of associated hyperlipidemia. Am J Med Sci. 2011 May;341(5):394-8. doi: 10.1097/MAJ.0b013e3181ff8eeb.
PubMed 21233693Boehncke S, Salgo R, Garbaraviciene J, Beschmann H, Hardt K, Diehl S, Fichtlscherer S, Thaci D, Boehncke WH. Effective continuous systemic therapy of severe plaque-type psoriasis is accompanied by amelioration of biomarkers of cardiovascular risk: results of a prospective longitudinal observational study. J Eur Acad Dermatol Venereol. 2011 Oct;25(10):1187-93. doi: 10.1111/j.1468-3083.2010.03947.x. Epub 2011 Jan 17.
PubMed 21241371Mehta NN, Yu Y, Saboury B, Foroughi N, Krishnamoorthy P, Raper A, Baer A, Antigua J, Van Voorhees AS, Torigian DA, Alavi A, Gelfand JM. Systemic and vascular inflammation in patients with moderate to severe psoriasis as measured by [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG-PET/CT): a pilot study. Arch Dermatol. 2011 Sep;147(9):1031-9. doi: 10.1001/archdermatol.2011.119. Epub 2011 May 16.
PubMed 21576552Bissonnette R, Tardif JC, Harel F, Pressacco J, Bolduc C, Guertin MC. Effects of the tumor necrosis factor-alpha antagonist adalimumab on arterial inflammation assessed by positron emission tomography in patients with psoriasis: results of a randomized controlled trial. Circ Cardiovasc Imaging. 2013 Jan 1;6(1):83-90. doi: 10.1161/CIRCIMAGING.112.975730. Epub 2012 Nov 30.
PubMed 23204039
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARDIOVASCULAR RISK FACTORS IN A SPANISH POPULATION OF PATIENTS WITH MODERATE-TO-SEVERE PSORIASIS VULGARIS, WITH OR WITHOUT ARTHRITIS, TREATED WITH ANTI-TNF IN REAL CLINICAL PRACTICE. ANALYSIS OF THE INFLUENCE OF METABOLIC SYNDROME ON TREATMENT EFFICACY.
- ClinicalTrials.gov ID
- NCT01753245
- Acronym / sponsor ID
- JRR-ANT-2012-01
- Conditions
- Psoriasis Vulgaris, Metabolic Syndrome
- Keywords
- Anti-TNF drugs efficacy, Moderate-to-severe psoriasis vulgaris, Gene polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Juan RuanoOther government
- Collaborators
- Pfizer
- Study start
- Dec 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 20 Dec 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.
It has been reported in various epidemiological studies that patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, have an increased frequency of cardiovascular risk factors, such as hypertension, obesity, type-2 diabetes mellitus (T2DM, and metabolic syndrome (MetS). The presence of endothelial dysfunction in early stages, especially in moderate-to-severe plaque psoriasis forms, could explain the higher prevalence of cardiovascular disease and mortality observed in this population. Existing evidence showing improvement in psoriasis after correcting some factors, such as obesity or hypercholesterolemia, and the reduction of certain surrogate markers of cardiovascular risk with different modalities of psoriasis treatment suggest a biological interaction between the two diseases beyond mere epidemiological association. Recently published results support this hypothesis and suggest that the link between psoriasis and cardiovascular disease could be the existence of an inflammatory state in different organs, including skin, joints, adipose and hepatic tissue, and vascular endothelium (16). Patients with MetS have an increased risk of developing T2DM and cardiovascular disease. This syndrome is characterized by the association of an adipose tissue inflammatory state and diminished sensitivity to insulin. In recent years, a new mechanism participating in the development of MetS has been added: the Wnt signaling pathway. Polymorphisms in genes of the Wnt signaling pathway have been associated with metabolic abnormalities that predispose to cardiovascular disease, the development of moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, and response to treatment with anti-TNF-alpha.
This study aims to describe the cardiovascular risk factors of a Spanish population of patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis,treated with anti-TNF under routine clinical practice conditions. Possible differences in efficacy relative to the presence or absence of criteria of metabolic syndrome will be analyzed. Similarly, we will explore the role of markers of inflammatory activity and genetic polymorphisms in the Wnt pathway in predicting response to treatment during the first year.
Detailed description
- Eligibility criteria: 1.1. Inclusion criteria:
- -Age >18 ys.
- -Male and female.
- -Moderate-to-severe psoriasis vulgaris, with or without psoriatic arthritis.
- -Treated with anti-TNF drugs (infliximab, etanercept, adalimumab). 1.2. Exclusion criteria: <!-- -->
- -Enrolled in another clinical trial.
- -Lack of clinical information at the hospital database.
- Objectives:
2.1. Primary objective: Evaluate the efficacy of anti-TNF- drugs in the treatment of patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, in terms of the presence or absence of cardiovascular risk factors, including metabolic syndrome.
2.2. Secondary objectives:
- 2.2.1. Analyze the possible modulatory role of genetic factors, such as Wnt pathway's gene polymorphisms, and other nongenetic factors on responsiveness to treatment with anti-TNF drugs in the overall study population and in the subgroup of patients with metabolic syndrome.
- 2.2.2. Describe the cardiovascular risk factors in patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, treated with anti-TNF- in the Spanish population under routine clinical practice conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Metabolic Syndrome | – | –Patients without Metabolic Syndrome criteria (OMS). |
| Metabolic Syndrome | – | –Patients with Metabolic Syndrome criteria (OMS). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- -Moderate-to-severe psoriasis treated >1 ys with anti-TNFalpha drugs at Reina Sofia University Hospital
Key inclusion criteria (3 listed)
- Moderate-to-severe psoriasis treated >1 ys with anti-TNFalpha drugs
- Age >18 ys/<80 ys
- With or without psoriatic arthritis
Key exclusion criteria (3 listed)
- Enrolled in another trial
- Lack of clinical information
- Pregnant
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
Role of Metabolic Syndrome on anti-TNF-drug efficacy.
Time frame: After one year of treatment
Evaluate the efficacy of anti-TNF-drugs in themoderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, in terms of the presence or absence of cardiovascular risk factors, including metabolic syndrome.
1 secondary outcome
Effect of 'Wnt pathway' genetic polymorphisms on anti-TNF-drug efficacy
Time frame: First year of treament
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
- Background: PubMed 21055711Gisondi P, Farina S, Giordano MV, Girolomoni G. Usefulness of the framingham risk score in patients with chronic psoriasis. Am J Cardiol. 2010 Dec 15;106(12):1754-7. doi: 10.1016/j.amjcard.2010.08.016. Epub 2010 Nov 4.
- Background: PubMed 20711266Choi WJ, Park EJ, Kwon IH, Kim KH, Kim KJ. Association between Psoriasis and Cardiovascular Risk Factors in Korean Patients. Ann Dermatol. 2010 Aug;22(3):300-6. doi: 10.5021/ad.2010.22.3.300. Epub 2010 Aug 5.
- Background: PubMed 2147927Limbrock GJ, Hoyer H, Scheying H. Drooling, chewing and swallowing dysfunctions in children with cerebral palsy: treatment according to Castillo-Morales. ASDC J Dent Child. 1990 Nov-Dec;57(6):445-51.
- Background: PubMed 20618468Karadag AS, Yavuz B, Ertugrul DT, Akin KO, Yalcin AA, Deveci OS, Ata N, Kucukazman M, Dal K. Is psoriasis a pre-atherosclerotic disease? Increased insulin resistance and impaired endothelial function in patients with psoriasis. Int J Dermatol. 2010 Jun;49(6):642-6. doi: 10.1111/j.1365-4632.2009.04358.x.
- Background: PubMed 20443997Prey S, Paul C, Bronsard V, Puzenat E, Gourraud PA, Aractingi S, Aubin F, Bagot M, Cribier B, Joly P, Jullien D, Le Maitre M, Richard-Lallemand MA, Ortonne JP. Cardiovascular risk factors in patients with plaque psoriasis: a systematic review of epidemiological studies. J Eur Acad Dermatol Venereol. 2010 Apr;24 Suppl 2:23-30. doi: 10.1111/j.1468-3083.2009.03564.x.
- Background: PubMed 22654590Zindanci I, Albayrak O, Kavala M, Kocaturk E, Can B, Sudogan S, Koc M. Prevalence of metabolic syndrome in patients with psoriasis. ScientificWorldJournal. 2012;2012:312463. doi: 10.1100/2012/312463. Epub 2012 Apr 24.
- Background: PubMed 20415820Alsufyani MA, Golant AK, Lebwohl M. Psoriasis and the metabolic syndrome. Dermatol Ther. 2010 Mar-Apr;23(2):137-43. doi: 10.1111/j.1529-8019.2010.01307.x.
- Background: PubMed 20819085Martyn-Simmons CL, Ranawaka RR, Chowienczyk P, Crook MA, Marber MS, Smith CH, Barker JN. A prospective case-controlled cohort study of endothelial function in patients with moderate to severe psoriasis. Br J Dermatol. 2011 Jan;164(1):26-32. doi: 10.1111/j.1365-2133.2010.10031.x. Epub 2010 Nov 8.
- Background: PubMed 20635857Ardic I, Kaya MG, Yarlioglues M, Karadag Z, Dogan A, Yildiz H, Dogdu O, Zencir C, Aktas E, Ergin A. Impaired aortic elastic properties in normotensive patients with psoriasis. Blood Press. 2010 Dec;19(6):351-8. doi: 10.3109/08037051.2010.505322. Epub 2010 Jul 16.
- Background: PubMed 20633008Abuabara K, Azfar RS, Shin DB, Neimann AL, Troxel AB, Gelfand JM. Cause-specific mortality in patients with severe psoriasis: a population-based cohort study in the U.K. Br J Dermatol. 2010 Sep;163(3):586-92. doi: 10.1111/j.1365-2133.2010.09941.x.
- Background: PubMed 18996858Gisondi P, Del Giglio M, Di Francesco V, Zamboni M, Girolomoni G. Weight loss improves the response of obese patients with moderate-to-severe chronic plaque psoriasis to low-dose cyclosporine therapy: a randomized, controlled, investigator-blinded clinical trial. Am J Clin Nutr. 2008 Nov;88(5):1242-7. doi: 10.3945/ajcn.2008.26427.
- Background: PubMed 21233693Ghazizadeh R, Tosa M, Ghazizadeh M. Clinical improvement in psoriasis with treatment of associated hyperlipidemia. Am J Med Sci. 2011 May;341(5):394-8. doi: 10.1097/MAJ.0b013e3181ff8eeb.
- Reina Sofia University HospitalLink provided by the sponsor.
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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.
Juan Ruano, M.D., Ph.D., Ms. C. principal investigator
Departament of Dermatology. Reina Sofia University Hospital.
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 Psoriasis Vulgaris and Metabolic Syndrome, run by Juan Ruano at 1 site 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 3 inclusion and 3 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 13 Mar 2014. 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 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.
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?
Role of Metabolic Syndrome on anti-TNF-drug efficacy. (time frame: After one year of treatment). 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 NCT01753245, which also lists 39 linked publications.
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 13 Mar 2014.