An observational study in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 1 site in Montenegro. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-01.
Sponsored by Hoffmann-La Roche · Observational
This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 50 is below the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with RA and an inadequate response to non-biologic DMARDs.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), will be observed. The choice of therapy will be based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
Drug: Tocilizumab
Participants will receive tocilizumab treatment according to effective official SPC. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
Also known as: RoActemra, L04AC07
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs.
Time frame: Baseline up to Week 24
Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria
EULAR response was based on 28-joint disease activity score (DAS28). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score). Good responders had a CFB greater than (\>) 1.2 with a DAS28 score less than or equal to (\<=) 3.2; moderate responders had a CFB \>1.2 with a DAS28 score \>3.2 to \<= 5.1 or a change from baseline \>0.6 to \<= 1.2 with a DAS28 score \<= 5.1; non-responders had a CFB \<=0.6 or CFB \>0.6 to \<=1.2 with DAS28 \>5.1. Number of participants who achieved EULAR good response and EULAR moderate response were reported.
Time frame: Baseline, Week 24
Number of Participants Who Discontinued Treatment Due to Lack of Efficacy
Time frame: Baseline up to Week 24
Time to Discontinuation Due to Lack of Efficacy
Time frame: Baseline up to Week 24
| Milestone | Tocilizumab in Moderate to Severe Active RA |
|---|---|
| Started | 50 |
| Completed | 48 |
| Not completed | 2 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Lack of motivation for treatment | 1 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs.
| participants | Tocilizumab in Moderate to Severe Active RA |
|---|---|
| SAEs | 0 |
| AEs | 38 |
EULAR response was based on 28-joint disease activity score (DAS28). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score). Good responders had a CFB greater than (\>) 1.2 with a DAS28 score less than or equal to (\<=) 3.2; moderate responders had a CFB \>1.2 with a DAS28 score \>3.2 to \<= 5.1 or a change from baseline \>0.6 to \<= 1.2 with a DAS28 score \<= 5.1; non-responders had a CFB \<=0.6 or CFB \>0.6 to \<=1.2 with DAS28 \>5.1. Number of participants who achieved EULAR good response and EULAR moderate response were reported.
| participants | Tocilizumab in Moderate to Severe Active RA |
|---|---|
| EULAR Good Response | 0 |
| EULAR Moderate Response | 40 |
| participants | Tocilizumab in Moderate to Severe Active RA |
|---|---|
| Number of Participants Who Discontinued Treatment Due to Lack of Efficacy | 0 |
No measurements were reported for this outcome.
Collected over Baseline up to Week 24. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tocilizumab in Moderate to Severe Active RA | — | 0/50 (0%) | 38/50 (76%) |
| Event | Tocilizumab in Moderate to Severe Active RA |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 15/50 |
| Hepatic transaminases increasedInvestigations | 10/50 |
| HypercholesterolemiaMetabolism and nutrition disorders | 9/50 |
| Leukopenia with neutropeniaBlood and lymphatic system disorders | 8/50 |
| HypertensionVascular disorders | 2/50 |
| PancytopeniaBlood and lymphatic system disorders | 2/50 |
| LeukopeniaBlood and lymphatic system disorders | 2/50 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/50 |
| LeukocytosisBlood and lymphatic system disorders | 1/50 |
| GastralgiaGastrointestinal disorders | 1/50 |
All participants who were enrolled in the study.
| Age, Continuous(years) | Tocilizumab in Moderate to Severe Active RA |
|---|---|
| Mean | 51.9 ± 11.1 |
| Sex: Female, Male(Participants) | Tocilizumab in Moderate to Severe Active RA |
|---|---|
| Female | 41 |
| Male | 9 |
The record gives a start of May 2012, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2016, 2 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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