Rheumatoid ArthritisNCT01338545
An Observational Study of Dosage Patterns in Routine Clinical Practice in Patients With Rheumatoid Arthritis (ACT-LIFE)
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 48 sites in 2 countries.
Trial summary
This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 400 participants
- Where
- 48 sitesin 2 countries
- Study dates
- Jul 2010to Sep 2012
- 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 with rheumatoid arthritis initiated on treatment with RoActemra/Actemra after at least one previous DMARD or TNF-inhibitor treatment
Who may be able to join
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis (RA) of at least 6 months duration
- Non-responder or intolerant to at least one DMARD or TNF inhibitor treatment
- Initiated on treatment with RoActemra according to Summary of Product Characteristics (SPC) indications
Who cannot join
- History of autoimmune disease or of any joint inflammatory disease other than RA
- Pregnant or lactating women
- Patients who have started RoActemra treatment in a clinical trial or for compassionate use
- Treatment with any investigational drug in the previous 4 weeks (or at least 5 times the half-life of the drug)
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
Spain47 sites
Study site
A Coruña, La Coruña, 15006
Study site
Alcalá de Henares, Madrid, 28805
Study site
Alcorcón, Madrid, 28922
Study site
Alzira, Valencia, 46600
Study site
Barakaldo, Vizcaya, 48903
Study site
Barcelona, Barcelona, 08036
Study site
Barcelona, Barcelona, 08907
Study site
Bilbao, Vizcaya, 48013
Study site
Cartagena, Murcia, 30203
Study site
Castellon, Castellon, 12004
Study site
Córdoba, Cordoba, 14004
Study site
Donostia / San Sebastian, Guipuzcoa, 20080
Study site
El Escorial, Madrid, 28200
Study site
El Palmar, Murcia, 30120
Study site
Elche, Alicante, 03203
Study site
Elda, Alicante, 03600
Study site
Girona, Girona, 17002
Study site
Granada, Granada, 18003
Study site
Granada, Granada, 18014
Study site
Huelva, Huelva, 21005
Study site
Jerez de la Frontera, Cadiz, 11407
Study site
Logroño, La Rioja, 26006
Study site
Lorca, Murcia, 30800
Study site
Madrid, Madrid, 28006
Study site
Madrid, Madrid, 28041
Study site
Madrid, Madrid, 28046
Study site
Madrid, Madrid, 28222
Study site
Madrid, Madrid, 28905
Study site
Madrid, Madrid, 28935
Study site
Málaga, Malaga, 29009
Study site
Murcia, Murcia, 30008
Study site
Ourense, Orense, 32005
Study site
Pamplona, Navarre, 31008
Study site
Sabadell, Barcelona, 08208
Study site
San Juan, Valencia, 03550
Study site
Sant Joan Despí, Barcelona, 08970
Study site
Santander, Cantabria, 39008
Study site
Santiago de Compostela, La Coruña, 15706
Study site
Seville, Sevilla, 41009
Study site
Toledo, Toledo, 45004
Study site
Torrelavega, Cantabria, 39300
Study site
Valencia, Valencia, 46010
Study site
Valencia, Valencia, 46015
Study site
Valencia, Valencia, 46017
Study site
Valenica, Valencia, 46009
Study site
Vigo, Pontevedra, 36204
Study site
Vinaròs, Castellon, 12500
About this study
Official title: A Multi-centre Observational Study to Describe Usage and Dosification Patterns of RoActemra (Tocilizumab) Treatment in Rheumatoid Arthritis (RA) Patients in the Routine Clinical Practice. ACT-LIFE Study
This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from each patients for 12 months.
- Conditions
- Rheumatoid Arthritis
- 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 group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons
Measured: 12 months
Secondary outcomes (7)
Safety: Incidence of adverse events
Measured: 12 months
Change in disease activity (disease activity score DAS28/ simple disease activity index SDAI)
Measured: 12 months
Response rate according to EULAR (European League Against Rheumatism) criteria
Measured: 12 months
Quality of life (Visual Analogue Scales, Health Assessment Questionnaire)
Measured: 12 months
Response/tolerance with regard to pretreatment with either DMARDs or TNF inhibitors
Measured: 12 months
Effect on DMARD tolerance/dosage in combination therapy
Measured: 12 months
Dosages used in clinical practice
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startJul 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 400 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
- NCT01338545
- Sponsor's protocol ID
- ML25264
- Status last verified
- Nov 2016
- First submitted
- 18 Apr 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Observational Study to Describe Usage and Dosification Patterns of RoActemra (Tocilizumab) Treatment in Rheumatoid Arthritis (RA) Patients in the Routine Clinical Practice. ACT-LIFE Study
- ClinicalTrials.gov ID
- NCT01338545
- Acronym / sponsor ID
- ML25264
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 19 Apr 2011 (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.
This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from each patients for 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra after at least one previous DMARD or TNF-inhibitor treatment
Key inclusion criteria (4 listed)
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis (RA) of at least 6 months duration
- Non-responder or intolerant to at least one DMARD or TNF inhibitor treatment
- Initiated on treatment with RoActemra according to Summary of Product Characteristics (SPC) indications
Key exclusion criteria (4 listed)
- History of autoimmune disease or of any joint inflammatory disease other than RA
- Pregnant or lactating women
- Patients who have started RoActemra treatment in a clinical trial or for compassionate use
- Treatment with any investigational drug in the previous 4 weeks (or at least 5 times the half-life of the drug)
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
Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons
Time frame: 12 months
7 secondary outcomes
Safety: Incidence of adverse events
Time frame: 12 months
Change in disease activity (disease activity score DAS28/ simple disease activity index SDAI)
Time frame: 12 months
Response rate according to EULAR (European League Against Rheumatism) criteria
Time frame: 12 months
Quality of life (Visual Analogue Scales, Health Assessment Questionnaire)
Time frame: 12 months
Response/tolerance with regard to pretreatment with either DMARDs or TNF inhibitors
Time frame: 12 months
Effect on DMARD tolerance/dosage in combination therapy
Time frame: 12 months
Dosages used in clinical practice
Time frame: 12 months
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 2 Nov 2016.
Related trials for Rheumatoid Arthritis
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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
48 sites in 2 countries: 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 48 sites in 2 countries.
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 4 inclusion and 4 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 48 sites in Spain, United States. 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?
Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.