Rheumatoid Arthritis
Conditions
Brief summary
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.
Interventions
DRUGTocilizumab
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.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate to severe active RA (European League Against Rheumatism \[EULAR\] criteria) * Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists * Initiating treatment with tocilizumab according to SPC
Exclusion criteria
* Rheumatic autoimmune disease other than RA * Prior history or current inflammatory joint disease other than RA * Previous treatment with any biological drug used in the treatment of RA * Previous treatment with tocilizumab * Any contraindication to treatment with tocilizumab * Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment * Pregnant women or nursing (breastfeeding) mothers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Baseline up to Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria | Baseline, Week 24 | 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. |
| Number of Participants Who Discontinued Treatment Due to Lack of Efficacy | Baseline up to Week 24 | — |
| Time to Discontinuation Due to Lack of Efficacy | Baseline up to Week 24 | — |
Countries
Montenegro
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tocilizumab in Moderate to Severe Active RA Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of motivation for treatment | 1 |
| Overall Study | Pregnancy | 1 |
Baseline characteristics
| Characteristic | Tocilizumab in Moderate to Severe Active RA |
|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 38 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
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
Population: All participants enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab in Moderate to Severe Active RA | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAEs | 0 participants |
| Tocilizumab in Moderate to Severe Active RA | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AEs | 38 participants |
Secondary
Number of Participants Who Discontinued Treatment Due to Lack of Efficacy
Time frame: Baseline up to Week 24
Population: All participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab in Moderate to Severe Active RA | Number of Participants Who Discontinued Treatment Due to Lack of Efficacy | 0 participants |
Secondary
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
Population: All participants enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab in Moderate to Severe Active RA | Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria | EULAR Good Response | 0 participants |
| Tocilizumab in Moderate to Severe Active RA | Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria | EULAR Moderate Response | 40 participants |
Secondary
Time to Discontinuation Due to Lack of Efficacy
Time frame: Baseline up to Week 24
Population: As none of the participants discontinued treatment due to lack of efficacy, this outcome measure was not estimable.