Rheumatoid ArthritisNCT02534311
A Phase IV Study to Evaluate the Effect of Subcutaneous (SC) Tocilizumab Administered to Participants With Rheumatoid Arthritis (RA) Assessed Using Disease Activity Score (DAS28)
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 5 sites in Slovakia.
Trial summary
The purpose of this clinical trial is to prospectively evaluate RA activity using the assessment of change in DAS28 under local conditions in Slovakia in participants who are treated with subcutaneously administered tocilizumab pursuant to the recommendations of the Ministry of Health of the Slovak Republic in order… 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
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 5 sitesSlovakia
- Study dates
- 13 Oct 2015to 1 Dec 2015
- 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: Moderate to severe RA participants who are treated with tocilizumab
Who may be able to join
- Participants with age greater than or equal to (>=) 18 years
- Participants with moderate to severe active RA (DAS28 >=3.2) who did not respond sufficiently to or did not tolerate previous treatment with one or several disease-modifying antirheumatic drugs (DMARDs), irrespective of whether they were of biological or synthetic nature
- Participants eligible for the treatment with subcutaneously administered tocilizumab, as decided by the doctor in accordance with summary of product characteristics (SPC) and standard therapeutic procedures, who were not previously treated with tocilizumab and did not receive any other biological treatment for RA in the past either
- Assignment of participants for observation using the treatment described above is clearly separated from the physician's decision to prescribe the treatment to the patient.
- Pulmonologist's consent for chest X-ray and quantiferon test with commencement of biological treatment
Who cannot join
- Hepatitis B surface antigen (HBsAg,) hepatitis C virus (HCV) or human immunodeficiency virus (HIV) positivity
- History of severe allergic or anaphylactic responses to human or humanized murine monoclonal antibodies
- History of intestinal ulcerations or diverticulitis
- Active hepatopathy with more than threefold increase of alanine transaminase (ALT) or aspartate transaminase (AST)
- Thrombocytes <100,000 per cubic milliliters (/mm^3), less than (<) 3,000 mm^3, absolute neutrophil count < 2,000 mm^3
- Women of childbearing age (without medically confirmed sterility, e.g. following hysterectomy, ovariectomy, menopause lasting 2 years) who do not accept the use of a suitable form of contraception (e.g. barrier methods of contraception in the participant and partner, contraceptive pills or patches, hormonal implants, spermicidal agents in combination with barrier method of contraception, intrauterine device)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Slovakia5 sites
Study site
Banská Bystrica, 975 17
Study site
Bratislava, 813 69
Study site
Bratislava, 826 06
Study site
Nitra, 950 01
Study site
Piešťany, 921 01
About this study
Official title: Prospective Evaluation of Rheumatoid Arthritis Activity Using DAS28 in Patients Treated With Subcutaneously Administered Tocilizumab on Local Level
The purpose of this clinical trial is to prospectively evaluate RA activity using the assessment of change in DAS28 under local conditions in Slovakia in participants who are treated with subcutaneously administered tocilizumab pursuant to the recommendations of the Ministry of Health of the Slovak Republic in order to better assess the disease activity and impairment of the joint function.
- 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
Tocilizumab will be administered at 162 mg SC injection for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Participants will receive tocilizumab (162 milligrams [mg]) SC injection for 48 weeks. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change from baseline in DAS28
Measured: up to Week 24
Average change from baseline in DAS28
Measured: up to Week 48
Secondary outcomes (8)
Percent of participants achieving clinical remission defined as a DAS28 <2.6
Measured: Baseline, Week 12, 24, 36, and 48
Percentage of participants achieving a DAS28 >=3.2
Measured: Baseline, Week 12, 24, 36, and 48
Evaluation of participant's pain using visual analogue scale (VAS)
Measured: Baseline, Week 12, 24, 36, and 48
Evaluation of the disease activity by participant using VAS
Measured: Baseline, Week 12, 24, 36, and 48
Evaluation of the disease activity by Doctor using VAS
Measured: Baseline, Week 12, 24, 36, and 48
DAS28-joint count (erythrocyte sedimentation rate) [DAS28(ESR)] score
Measured: Baseline, Week 12, 24, 36, and 48
DAS28-joint count (C-reactive protein) [DAS28(CRP)] score
Measured: Baseline, Week 12, 24, 36, and 48
Absolute and percent change in the Health Assessment Questionnaire (HAQ)
Measured: Baseline, Week 12, 24, 36, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study start13 Oct 2015
- Primary completion1 Dec 2015
- Study completion1 Dec 2015
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
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
- NCT02534311
- Sponsor's protocol ID
- ML29712
- Status last verified
- Feb 2018
- First submitted
- 25 Aug 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Rheumatoid Arthritis Activity Using DAS28 in Patients Treated With Subcutaneously Administered Tocilizumab on Local Level
- ClinicalTrials.gov ID
- NCT02534311
- Acronym / sponsor ID
- ML29712
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2015 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 27 Aug 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 purpose of this clinical trial is to prospectively evaluate RA activity using the assessment of change in DAS28 under local conditions in Slovakia in participants who are treated with subcutaneously administered tocilizumab pursuant to the recommendations of the Ministry of Health of the Slovak Republic in order to better assess the disease activity and impairment of the joint function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | – | Drug: TocilizumabParticipants will receive tocilizumab (162 milligrams [mg]) SC injection for 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate to severe RA participants who are treated with tocilizumab
Key inclusion criteria (5 listed)
- Participants with age greater than or equal to (>=) 18 years
- Participants with moderate to severe active RA (DAS28 >=3.2) who did not respond sufficiently to or did not tolerate previous treatment with one or several disease-modifying antirheumatic drugs (DMARDs), irrespective of whether they were of biological or synthetic nature
- Participants eligible for the treatment with subcutaneously administered tocilizumab, as decided by the doctor in accordance with summary of product characteristics (SPC) and standard therapeutic procedures, who were not previously treated with tocilizumab and did not receive any other biological treatment for RA in the past either
- Assignment of participants for observation using the treatment described above is clearly separated from the physician's decision to prescribe the treatment to the patient.
- Pulmonologist's consent for chest X-ray and quantiferon test with commencement of biological treatment
Key exclusion criteria (6 listed)
- Hepatitis B surface antigen (HBsAg,) hepatitis C virus (HCV) or human immunodeficiency virus (HIV) positivity
- History of severe allergic or anaphylactic responses to human or humanized murine monoclonal antibodies
- History of intestinal ulcerations or diverticulitis
- Active hepatopathy with more than threefold increase of alanine transaminase (ALT) or aspartate transaminase (AST)
- Thrombocytes <100,000 per cubic milliliters (/mm^3), less than (<) 3,000 mm^3, absolute neutrophil count < 2,000 mm^3
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: RoActemraTocilizumab will be administered at 162 mg SC injection for 48 weeks. | Drug | Tocilizumab |
Primary outcome
Average change from baseline in DAS28
Time frame: up to Week 24
Average change from baseline in DAS28
Time frame: up to Week 48
8 secondary outcomes
Percent of participants achieving clinical remission defined as a DAS28 <2.6
Time frame: Baseline, Week 12, 24, 36, and 48
Percentage of participants achieving a DAS28 >=3.2
Time frame: Baseline, Week 12, 24, 36, and 48
Evaluation of participant's pain using visual analogue scale (VAS)
Time frame: Baseline, Week 12, 24, 36, and 48
Evaluation of the disease activity by participant using VAS
Time frame: Baseline, Week 12, 24, 36, and 48
Evaluation of the disease activity by Doctor using VAS
Time frame: Baseline, Week 12, 24, 36, and 48
DAS28-joint count (erythrocyte sedimentation rate) [DAS28(ESR)] score
Time frame: Baseline, Week 12, 24, 36, and 48
DAS28-joint count (C-reactive protein) [DAS28(CRP)] score
Time frame: Baseline, Week 12, 24, 36, and 48
Absolute and percent change in the Health Assessment Questionnaire (HAQ)
Time frame: Baseline, Week 12, 24, 36, and 48
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 28 Feb 2018.
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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
5 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 5 sites in Slovakia.
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 5 inclusion and 6 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Slovakia. 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?
Average change from baseline in DAS28 (time frame: up to Week 24). The study lists 2 primary outcomes in all. 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 28 Feb 2018.