Rheumatoid ArthritisGISEANCT01543594
Italian Registry of Arthritis on Biologic Therapy
An observational study of Rheumatoid Arthritis, run by Gruppo Italiano Studio Early Arthritis at 1 site in Italy.
Trial summary
The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a fundamental discovery to treat rheumatic patients whose disease appears to be refractory to conventional therapy. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to Dec 2025
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients affected by active polyarthritis beginning conventional biologic drugs
Who may be able to join
- Clinical diagnosis of Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis
- Patients with active disease refractory to traditional disease modifying drugs (methotrexate, leflunomide, sulphasalazine, cyclosporine, hydrossiclorochine)
- Patients eligible to begin conventional biologic therapy
Who cannot join
- Any criteria excluding treatment with biologic drugs according to international guidelines
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
GISEA
Bari, 70124
Giovanni Lapadula, MD, +390805478866, g.lapadula@reumabari.uniba.it
Giovanni Lapadula, MD
About this study
Official title: Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis
The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a fundamental discovery to treat rheumatic patients whose disease appears to be refractory to conventional therapy. These biologic drugs have been registered for human therapy from a few years, thereby the investigators miss long-term data for safety and efficacy. Aim of this study is to register all the clinical data of patients with rheumatoid arthritis and spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term safety and efficacy in the real life.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Seronegative polyarthritis, Biologic drugs, Safety efficacy biologics polyarthritis
- Medical subject headings
- Arthritis, Rheumatoid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJan 2009
- Primary completionMay 2022 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Studio Early Arthritis
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Prof. Florenzo Iannone, Gruppo Italiano Studio Early Arthritis
- Investigators
- Florenzo Iannone, MD, Study chair, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543594
- Sponsor's protocol ID
- DG-624
- Other IDs
- 2012
- Acronym
- GISEA
- Status last verified
- Sep 2020
- First submitted
- 28 Feb 2012
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cacciapaglia F, Manfredi A, Erre G, Piga M, Sakellariou G, Viapiana O, Gremese E, Spinelli FR, Atzeni F, Bartoloni E. Correspondence on 'Characteristics associated with hospitalisation for COVID-19 in people with rheumatic disease: data from the COVID-19 global rheumatology alliance physician-reported registry' by Gianfrancesco M et al. The impact of cardiovascular comorbidity on COVID-19 infection in a large cohort of rheumatoid arthritis patients. Ann Rheum Dis. 2023 Jul;82(7):e159. doi: 10.1136/annrheumdis-2020-218813. Epub 2020 Sep 15. No abstract available.
PubMed 32933920Iannone F, La Montagna G, Bagnato G, Gremese E, Giardina A, Lapadula G. Safety of etanercept and methotrexate in patients with rheumatoid arthritis and hepatitis C virus infection: a multicenter randomized clinical trial. J Rheumatol. 2014 Feb;41(2):286-92. doi: 10.3899/jrheum.130658. Epub 2014 Jan 15.
PubMed 24429167
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis
- ClinicalTrials.gov ID
- NCT01543594
- Acronym / sponsor ID
- GISEA / DG-624
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Seronegative polyarthritis, Biologic drugs, Safety efficacy biologics polyarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Gruppo Italiano Studio Early ArthritisResearch network
- Study start
- Jan 2009
- Primary completion
- May 2022 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Mar 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 biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a fundamental discovery to treat rheumatic patients whose disease appears to be refractory to conventional therapy. These biologic drugs have been registered for human therapy from a few years, thereby the investigators miss long-term data for safety and efficacy. Aim of this study is to register all the clinical data of patients with rheumatoid arthritis and spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term safety and efficacy in the real life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients affected by active polyarthritis beginning conventional biologic drugs
Key inclusion criteria (3 listed)
- Clinical diagnosis of Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis
- Patients with active disease refractory to traditional disease modifying drugs (methotrexate, leflunomide, sulphasalazine, cyclosporine, hydrossiclorochine)
- Patients eligible to begin conventional biologic therapy
Key exclusion criteria (1 listed)
- Any criteria excluding treatment with biologic drugs according to international guidelines
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Derived from this study: PubMed 32933920Cacciapaglia F, Manfredi A, Erre G, Piga M, Sakellariou G, Viapiana O, Gremese E, Spinelli FR, Atzeni F, Bartoloni E. Correspondence on 'Characteristics associated with hospitalisation for COVID-19 in people with rheumatic disease: data from the COVID-19 global rheumatology alliance physician-reported registry' by Gianfrancesco M et al. The impact of cardiovascular comorbidity on COVID-19 infection in a large cohort of rheumatoid arthritis patients. Ann Rheum Dis. 2023 Jul;82(7):e159. doi: 10.1136/annrheumdis-2020-218813. Epub 2020 Sep 15. No abstract available.
- Derived from this study: PubMed 24429167Iannone F, La Montagna G, Bagnato G, Gremese E, Giardina A, Lapadula G. Safety of etanercept and methotrexate in patients with rheumatoid arthritis and hepatitis C virus infection: a multicenter randomized clinical trial. J Rheumatol. 2014 Feb;41(2):286-92. doi: 10.3899/jrheum.130658. Epub 2014 Jan 15.
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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.
Florenzo Iannone, MD study chair
University of Bari
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 Rheumatoid Arthritis, run by Gruppo Italiano Studio Early Arthritis at 1 site in Italy.
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 1 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 29 Sep 2020. 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 Italy. 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?
Contact Giovanni Lapadula, MD (+390805478867, g.lapadula@reumbari.uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01543594, which also lists 2 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 29 Sep 2020.