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Rheumatoid ArthritisNCT02322801

Observational Safety Study of Rituximab in Patients Diagnosed With Rheumatoid Arthritis (RA) Who Did Not Respond Adequately to TNF-alpha Blocker

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 54 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This multi-center, observational, retrospective-prospective cohort study will investigate the safety of rituximab (MabThera) by collecting data from daily clinical practice on the use of rituximab and its relative clinical impact, particularly with regard to adverse events. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
How many people
209 participants
Where
54 sitesItaly
Study dates
Mar 2009to Nov 2011
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with RA who did not respond adequately to anti-TNF-alpha

Who may be able to join

  • Patients diagnosed with RA who did not respond adequately to anti-TNF-alpha and who started rituximab (RTX) treatment in the 12 months before site initiation and were still under treatment when enrollment starts

Who cannot join

  • Patients with serious infections

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

Italy54 sites

  • Study site

    Albano Laziale, Lazio, 00041

  • Study site

    Arenzano, Liguria, 16011

  • Study site

    Arezzo, Tuscany, 52100

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Brindisi, Apulia, 72100

  • Study site

    Cagliari, Sardinia, 09042

  • Study site

    Catania, Sicily, 95124

  • Study site

    Catania, Sicily, 95126

  • Study site

    Cremona, Lombardy, 26100

  • Study site

    Cuneo, Piedmont, 12100

  • Study site

    Florence, Tuscany, 50100

  • Study site

    Gorizia, Friuli Venezia Giulia, 34170

  • Study site

    Legnano, Lombardy, 20025

  • Study site

    Martina Franca, Apulia, 74015

  • Study site

    Massa, Tuscany, 54100

  • Study site

    Milan, Lombardy, 20122

  • Study site

    Milan, Lombardy, 20161

  • Study site

    Milan, Lombardy, 20162

  • Study site

    Monserrato, Sardinia, 09042

  • Study site

    Monza, Lombardy, 20052

  • Study site

    Mormanno, Calabria, 87026

  • Study site

    Naples, Campania, 80131

  • Study site

    Naples, Campania, 80144

  • Study site

    Novara, Piedmont, 28100

  • Study site

    Palermo, Sicily, 90127

  • Study site

    Palermo, Sicily, 90146

  • Study site

    Parma, Emilia-Romagna, 43100

  • Study site

    Pescara, Abruzzo, 65100

  • Study site

    Piacenza, Emilia-Romagna, 29100

  • Study site

    Pinerolo, Piedmont, 10064

  • Study site

    Pisa, Tuscany, 56100

  • Study site

    Pontedera, Tuscany, 56025

  • Study site

    Prato, Tuscany, 59100

  • Study site

    Rieti, Lazio, 02100

  • Study site

    Rome, Lazio, 00128

  • Study site

    Rome, Lazio, 00133

  • Study site

    Rome, Lazio, 00135

  • Study site

    Rome, Lazio, 00152

  • Study site

    Rome, Lazio, 00153

  • Study site

    Rome, Lazio, 00189

  • Study site

    Rozzano, Lombardy, 20089

  • Study site

    San Cesario di Lecce, Apulia, 73016

  • Study site

    San Daniele Del Friuli, Apulia, 33038

  • Study site

    Savona, Liguria, 17100

  • Study site

    Scafati, Campania, 84018

  • Study site

    Treviso, Veneto, 31100

  • Study site

    Trieste, Friuli Venezia Giulia, 34142

  • Study site

    Turin, Piedmont, 10126

  • Study site

    Turin, Piedmont, 10128

  • Study site

    Valeggio sul Mincio, Veneto, 37067

  • Study site

    Venezia, Veneto, 30127

  • Study site

    Verona, Veneto, 37134

  • Study site

    Vicenza, Veneto, 36100

  • Study site

    Viterbo, Lazio, 01100

Other trials in Italy

About this study

This multi-center, observational, retrospective-prospective cohort study will investigate the safety of rituximab (MabThera) by collecting data from daily clinical practice on the use of rituximab and its relative clinical impact, particularly with regard to adverse events. Data from each patient will be collected over 24 months after enrolment in the study. Target sample size is up to 325 patients.

Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02322801
Study groupRoleWhat they receive
CohortNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of patients with at least one grade 3 or 4 adverse event since starting RTX treatment and in the 24 months after study enrollment

    Measured: Up to 31 months (24 months each patient)

Secondary outcomes (6)

  1. Percent of patients with at least one severe adverse event (SAE)

    Measured: Up to 31 months (24 months each patient)

  2. Percent of patients who discontinued therapy with RTX

    Measured: Up to 31 months (24 months each patient)

  3. Time to "re-treatment" with RTX

    Measured: Up to 31 months (24 months each patient)

  4. Features of responders to RTX therapy in terms of co-morbidity and concomitant drugs

    Measured: Up to 31 months (24 months each patient)

  5. Time to response and duration of response to RTX

    Measured: Up to 31 months (24 months each patient)

  6. Percent of patients who achieve remission and relative quality of life (QoL) at 6, 12 and 24 months versus baseline

    Measured: Up to 31 months (24 months each patient)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2014 (estimated)
  2. Study startMar 2009
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

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
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02322801
Sponsor's protocol ID
ML21774
Status last verified
Nov 2016
First submitted
19 Dec 2014
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 54 sites 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 1 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: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites 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?

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?

Percent of patients with at least one grade 3 or 4 adverse event since starting RTX treatment and in the 24 months after study enrollment (time frame: Up to 31 months (24 months each patient)). 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 NCT02322801.

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 2 Nov 2016.

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