Rheumatoid ArthritisSIMPACTNCT02402686
Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 18 sites in Hungary.
Trial summary
The aim of this non-interventional study in Hungarian participants is to gather real life data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about pattern of usage of tocilizumab monotherapy in RA disease management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tocilizumab
- How many people
- 353 participants
- Where
- 18 sitesHungary
- Study dates
- 20 May 2015to 17 Dec 2018
- 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: Participants receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current SPC/local labeling and who have no contraindication to tocilizumab therapy as per the local label. This can include participants who have received tocilizumab SC monotherapy treatment within 8 weeks prior to the enrollment visit.
Who may be able to join
- Moderate to severe RA according to 2010 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) joint criteria
- Treatment with tocilizumab SC monotherapy for up to 8 weeks prior to enrollment, under the prescriptive authority of a physician who has made the decision to commence tocilizumab in accordance with the local label
- Methotrexate intolerance, or inadequate response to prior DMARDs and TNF inhibitors where continued methotrexate treatment was deemed inappropriate
Who cannot join
- Treatment with tocilizumab more than 8 weeks prior to enrollment
- Failure to meet local tocilizumab label indication criteria
- Treatment with any investigational agent within 4 weeks of beginning tocilizumab SC monotherapy
- Last methotrexate dose within 1 week of beginning tocilizumab SC monotherapy
- History of any other autoimmune or joint inflammatory disease
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Hungary18 sites
National Institute of Rheumatology and Physiotherapy; 4Th Rheumatology Department
Budapest, 1023
Budai Irgalmasrendi Kórház KHT. II. Reumatológia
Budapest, 1027
Magyar Honvedseg Honved Korhaz, Reumatologia
Budapest, 1062
Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék
Debrecen, 4032
Markhot Ferenc Hospital; Dep. of Rheumatology
Eger, 3300
Vaszary Kolos Kórház
Esztergom, 2500
Petz Aladár County Teaching Hospital
Győr, 9023
Pandy Kalman Hospital; Dept. of Infectious Diseases
Gyula, 5700
Szent Andras Reumakorhaz; Reumatologia
Hévíz, 8380
Bacs-Kiskun Megyei Korhaz
Kecskemét, 6000
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, 2084
Szent Ferenc Kórház; Reumatológia
Miskolc, 3529
Szabolcs-Szatmar-Bereg Megyei Josa Andras Korhaz; Reumatologia
Nyíregyháza, 4400
Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika
Pécs, 7632
Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont; Rheumatologiai Klinika
Szeged, 6724
Fejér Megyei Szent György Kórház; Reumatológiai Osztály
Székesfehérvár, 8000
Markusovszky Hospital
Szombathely, 9700
Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia
Veszprém, 8200
About this study
Official title: Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)
The aim of this non-interventional study in Hungarian participants is to gather real life data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about pattern of usage of tocilizumab monotherapy in RA disease management.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tocilizumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called RoActemra
Dosing and treatment duration of tocilizumab collected as part of this non-interventional study are at the discretion of the physician in accordance with local clinical practice and local labeling. Observation period is 24 weeks from first SC tocilizumab administration.
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab for RA in Routine Clinical Practice | Participants from routine clinical practice in Hungary who are receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling and who have no contraindication to tocilizumab therapy as per the local label are eligible for observation. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study
Measured: Baseline, end of study (up to 24 weeks)
Secondary outcomes (15)
Change in Clinical Disease Activity Index (CDAI) Score from Baseline to End of Study
Measured: Baseline, end of study (up to 24 weeks)
Percentage of Participants Achieving DAS28 Remission, as Defined by DAS28 Less Than or Equal to (≤) 2.6
Measured: Up to 24 weeks
Percentage of Participants Achieving CDAI Remission, as Defined by CDAI ≤2.8
Measured: Up to 24 weeks
Change in DAS28 from Baseline to End of Study in Different Monotherapy Subgroups
The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing disease-modifying antirheumatic drugs (DMARDs), 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics.
Measured: Baseline, end of study (up to 24 weeks)
Percentage of Participants Achieving DAS28 Remission in Different Monotherapy Subgroups, as Defined by DAS28 ≤2.6
The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing DMARDs, 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics.
Measured: Up to 24 weeks
Number of Tocilizumab SC Injections per Participant During Observational Treatment Period
Measured: Up to 24 weeks
Percentage of Participants Who Discontinued Tocilizumab, Categorized by the Reasons for the Discontinuations
Measured: Up to 24 weeks
Percentage of Participants on SC Tocilizumab First Line Monotherapy
Measured: Up to 24 weeks
Percentage of Participants with Reasons for SC Tocilizumab Monotherapy
Measured: Up to 24 weeks
Percentage of Participants Treated Previously with a Tumor Necrosis Factor (TNF) Inhibitor/Other Biologic and Low Dose Methotrexate (Less Than 10 Milligrams/Week)
Measured: Up to 24 weeks
Percentage of Participants with Other DMARDs Than Methotrexate Before Tocilizumab Monotherapy Initiation and at End of Observation Period
Measured: Baseline, Week 24
Percentage of Participants with Oral Steroid at Initiation of Tocilizumab SC Therapy and at End of Study
Measured: Baseline, Week 24
Percentage of Participants With Steroid Dose Reductions/Withdrawal at End of Observation Period
Measured: Week 24
Percentage of Participants with Steroid Tapering in Different Monotherapy Subgroups Who Achieved DAS28 Remission
The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing DMARDs, 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics.
Measured: Up to 24 weeks
Percentage of Participants with Adverse Events
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study start20 May 2015
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402686
- Sponsor's protocol ID
- ML29719
- Acronym
- SIMPACT
- Status last verified
- Dec 2019
- First submitted
- 25 Mar 2015
- Last updated
- 6 Dec 2019
- Results posted
- No
Publications
Nagy G, Geher P, Tamasi L, Drescher E, Keszthelyi P, Pulai J, Czirjak L, Szekanecz Z, Kiss G, Kovacs L. Real-world evidence on methotrexate-free subcutaneous tocilizumab therapy in patients with rheumatoid arthritis: 24-week data from the SIMPACT study. Rheumatol Adv Pract. 2022 May 16;6(2):rkac038. doi: 10.1093/rap/rkac038. eCollection 2022.
PubMed 35663154
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)
- ClinicalTrials.gov ID
- NCT02402686
- Acronym / sponsor ID
- SIMPACT / ML29719
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 20 May 2015 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 30 Mar 2015 (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 aim of this non-interventional study in Hungarian participants is to gather real life data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about pattern of usage of tocilizumab monotherapy in RA disease management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab for RA in Routine Clinical Practice | – | Drug: TocilizumabParticipants from routine clinical practice in Hungary who are receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling and who have no contraindication to tocilizumab therapy as per the local label are eligible for observation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current SPC/local labeling and who have no contraindication to tocilizumab therapy as per the local label. This can include participants who have received tocilizumab SC monotherapy treatment within 8 weeks prior to the enrollment visit.
Key inclusion criteria (3 listed)
- Moderate to severe RA according to 2010 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) joint criteria
- Treatment with tocilizumab SC monotherapy for up to 8 weeks prior to enrollment, under the prescriptive authority of a physician who has made the decision to commence tocilizumab in accordance with the local label
- Methotrexate intolerance, or inadequate response to prior DMARDs and TNF inhibitors where continued methotrexate treatment was deemed inappropriate
Key exclusion criteria (5 listed)
- Treatment with tocilizumab more than 8 weeks prior to enrollment
- Failure to meet local tocilizumab label indication criteria
- Treatment with any investigational agent within 4 weeks of beginning tocilizumab SC monotherapy
- Last methotrexate dose within 1 week of beginning tocilizumab SC monotherapy
- History of any other autoimmune or joint inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabAlso: RoActemraDosing and treatment duration of tocilizumab collected as part of this non-interventional study are at the discretion of the physician in accordance with local clinical practice and local labeling. Observation period is 24 weeks from first SC tocilizumab administration. | Drug | Tocilizumab for RA in Routine Clinical Practice |
Primary outcome
Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study
Time frame: Baseline, end of study (up to 24 weeks)
15 secondary outcomes
Change in Clinical Disease Activity Index (CDAI) Score from Baseline to End of Study
Time frame: Baseline, end of study (up to 24 weeks)
Percentage of Participants Achieving DAS28 Remission, as Defined by DAS28 Less Than or Equal to (≤) 2.6
Time frame: Up to 24 weeks
Percentage of Participants Achieving CDAI Remission, as Defined by CDAI ≤2.8
Time frame: Up to 24 weeks
Change in DAS28 from Baseline to End of Study in Different Monotherapy Subgroups
Time frame: Baseline, end of study (up to 24 weeks)
Percentage of Participants Achieving DAS28 Remission in Different Monotherapy Subgroups, as Defined by DAS28 ≤2.6
Time frame: Up to 24 weeks
Number of Tocilizumab SC Injections per Participant During Observational Treatment Period
Time frame: Up to 24 weeks
Percentage of Participants Who Discontinued Tocilizumab, Categorized by the Reasons for the Discontinuations
Time frame: Up to 24 weeks
Percentage of Participants on SC Tocilizumab First Line Monotherapy
Time frame: Up to 24 weeks
Percentage of Participants with Reasons for SC Tocilizumab Monotherapy
Time frame: Up to 24 weeks
Percentage of Participants Treated Previously with a Tumor Necrosis Factor (TNF) Inhibitor/Other Biologic and Low Dose Methotrexate (Less Than 10 Milligrams/Week)
Time frame: Up to 24 weeks
Percentage of Participants with Other DMARDs Than Methotrexate Before Tocilizumab Monotherapy Initiation and at End of Observation Period
Time frame: Baseline, Week 24
Percentage of Participants with Oral Steroid at Initiation of Tocilizumab SC Therapy and at End of Study
Time frame: Baseline, Week 24
Percentage of Participants With Steroid Dose Reductions/Withdrawal at End of Observation Period
Time frame: Week 24
Percentage of Participants with Steroid Tapering in Different Monotherapy Subgroups Who Achieved DAS28 Remission
Time frame: Up to 24 weeks
Percentage of Participants with Adverse Events
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Derived from this study: PubMed 35663154Nagy G, Geher P, Tamasi L, Drescher E, Keszthelyi P, Pulai J, Czirjak L, Szekanecz Z, Kiss G, Kovacs L. Real-world evidence on methotrexate-free subcutaneous tocilizumab therapy in patients with rheumatoid arthritis: 24-week data from the SIMPACT study. Rheumatol Adv Pract. 2022 May 16;6(2):rkac038. doi: 10.1093/rap/rkac038. eCollection 2022.
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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.
Clinical Trials study director
Hoffmann-La Roche
18 sites 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 Hoffmann-La Roche at 18 sites in Hungary.
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 5 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 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Hungary. 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?
Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study (time frame: Baseline, end of study (up to 24 weeks)). 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 NCT02402686, which also lists 1 linked publication.
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 6 Dec 2019.