Rheumatoid Arthritis
Conditions
Brief summary
This study will gather information on the safety and efficacy of patients with rheumatoid arthritis (RA) who are starting treatment with infliximab for the first time. Patients will be treated in the usual manner according to local guidelines and normal clinical practice.
Detailed description
Local patients, diagnosed with RA at the National Institute of Rheumatic Diseases, Piestany, Slovakia, can participate, if their physicians have decided to treat the patient with infliximab. Registration for the trial will be done on a voluntary basis.
Interventions
DRUGInfliximab
Infliximab given in accordance with the local summary of product characteristics
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subject must have been given patient leaflet, * Subject must not have ever received infliximab at the time of registration, * Subject must be a good candidate for infliximab as per Summary of Product Characteristics * Subject must sign the approved consent form
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment | Baseline, Week 14, and Week 54 | The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Participants can be scored on a range of 0 to 10, with lower scores indicating less disease activity. |
| Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria | Week 14 and Week 54 | Response to treatment was assessed by EULAR response criteria. According to these criteria, participants were characterized as good, moderate, or non-responders based on both DAS level attained and change in DAS. Good response was defined as \>1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of \>0.6 but ≤1.2 and DAS attained during follow-up of \>3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infliximab Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Lack of Efficacy | 10 |
Baseline characteristics
| Characteristic | Infliximab |
|---|---|
| Age, Continuous | 43.38 years STANDARD_DEVIATION 10.74 |
| Region of Enrollment Slovakia | 33 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment
The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Participants can be scored on a range of 0 to 10, with lower scores indicating less disease activity.
Time frame: Baseline, Week 14, and Week 54
Population: Thirty-three participants had a DAS 28 score at the beginning of treatment.~Twenty-eight participants had a DAS 28 score at Week 14.~Twenty-two participants had a DAS 28 score at Week 54.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infliximab | Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment | Baseline | 7.11 Units on a Scale | Standard Deviation 0.65 |
| Infliximab | Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment | Week 14 | 2.94 Units on a Scale | Standard Deviation 1.22 |
| Infliximab | Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment | Week 54 | 3.27 Units on a Scale | Standard Deviation 1.59 |
Primary
Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria
Response to treatment was assessed by EULAR response criteria. According to these criteria, participants were characterized as good, moderate, or non-responders based on both DAS level attained and change in DAS. Good response was defined as \>1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of \>0.6 but ≤1.2 and DAS attained during follow-up of \>3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.
Time frame: Week 14 and Week 54
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab | Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria | Week 14 | 27 Participants |
| Infliximab | Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria | Week 54 | 19 Participants |