Trial Outcomes & Findings for COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA (NCT NCT03649061)
NCT ID: NCT03649061
Last Updated: 2025-06-19
Results Overview
Analysis was based on an intention to treat population, which focused on all patients randomized into the study, irrespective if they actually received the randomized treatment. Fifty-five patients were allocated to Standard COBRA-Slim and 55 to COBRA-Slim Bio-induction. This measure is an indication of the total disease-activity over time or long-term effectiveness, a higher area under the curve indicates a higher disease activity over time and so a lower effectiveness over the time frame of the trial. The scale range for the duration of the trial (104 weeks) is 0.0 to 977.6 * remission: value below 270.4 * low disease activity: from 270.4 till 332.8 (included) * moderate disease activity: above 332.8 till 530.4 * high disease activity: above 530.4
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
276 participants
Primary outcome timeframe
baseline, w4, w8, w16, w24, w32, w40, w52, w64, w78, w92 and w104
Results posted on
2025-06-19
Participant Flow
Of the 284 patients screened, 276 were eligible for the trial and 122 met the criteria of early insufficient responders to an initial COBRA-Slim remission induction regimen. Of this last group 112 patients were randomized, however 2 were considered randomization errors, 10 patients were eligible for randomization but were not randomized per investigator decision.
All patients received a COBRA-Slim remission induction regimen, consisting of methotrexate (MTX) with a step-down scheme of glucocorticosteroids (GC). Patient not reaching low disease activity, based on DAS28CRP, before week 32 or DAS28CRP remission at week 32 were considered early insufficient responders and were eligible for randomization.
Participant milestones
| Measure |
Standard COBRA-Slim Induction
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme
|
COBRA-Slim Bio-induction
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard COBRA-Slim Induction
n=55 Participants
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme
|
COBRA-Slim Bio-induction
n=55 Participants
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=55 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=110 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=55 Participants
|
48 Participants
n=55 Participants
|
91 Participants
n=110 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=55 Participants
|
7 Participants
n=55 Participants
|
19 Participants
n=110 Participants
|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 13.1 • n=55 Participants
|
52.5 years
STANDARD_DEVIATION 12.9 • n=55 Participants
|
52.9 years
STANDARD_DEVIATION 13.0 • n=110 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=55 Participants
|
38 Participants
n=55 Participants
|
79 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=55 Participants
|
17 Participants
n=55 Participants
|
31 Participants
n=110 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
55 participants
n=55 Participants
|
55 participants
n=55 Participants
|
110 participants
n=110 Participants
|
|
smoking
never
|
22 Participants
n=55 Participants
|
19 Participants
n=55 Participants
|
41 Participants
n=110 Participants
|
|
smoking
past
|
14 Participants
n=55 Participants
|
13 Participants
n=55 Participants
|
27 Participants
n=110 Participants
|
|
smoking
current
|
19 Participants
n=55 Participants
|
23 Participants
n=55 Participants
|
42 Participants
n=110 Participants
|
|
Rheumatoid factor (RF)/Anti-citrullinated protein antibodies (ACPA ) status
positive
|
42 Participants
n=55 Participants
|
41 Participants
n=55 Participants
|
83 Participants
n=110 Participants
|
|
Rheumatoid factor (RF)/Anti-citrullinated protein antibodies (ACPA ) status
negative
|
13 Participants
n=55 Participants
|
14 Participants
n=55 Participants
|
27 Participants
n=110 Participants
|
|
Disease activity (DAS28CRP)
|
5.4 units on a scale
STANDARD_DEVIATION 1.1 • n=55 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 1.3 • n=55 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 1.2 • n=110 Participants
|
|
Disease duration
|
7.0 days
n=55 Participants
|
7.0 days
n=55 Participants
|
7.0 days
n=110 Participants
|
PRIMARY outcome
Timeframe: baseline, w4, w8, w16, w24, w32, w40, w52, w64, w78, w92 and w104Population: intention to treat (ITT) population
Analysis was based on an intention to treat population, which focused on all patients randomized into the study, irrespective if they actually received the randomized treatment. Fifty-five patients were allocated to Standard COBRA-Slim and 55 to COBRA-Slim Bio-induction. This measure is an indication of the total disease-activity over time or long-term effectiveness, a higher area under the curve indicates a higher disease activity over time and so a lower effectiveness over the time frame of the trial. The scale range for the duration of the trial (104 weeks) is 0.0 to 977.6 * remission: value below 270.4 * low disease activity: from 270.4 till 332.8 (included) * moderate disease activity: above 332.8 till 530.4 * high disease activity: above 530.4
Outcome measures
| Measure |
Standard COBRA-Slim Induction
n=55 Participants
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme
|
COBRA-Slim Bio-induction
n=55 Participants
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
|
|---|---|---|
|
Area Under Curve (AUC) of Disease Activity Score Based on a 28 Jointcount and C-reactive Protein (DAS28CRP)
|
297.4 units on a scale*week
Interval 277.1 to 317.7
|
300.7 units on a scale*week
Interval 282.3 to 319.1
|
SECONDARY outcome
Timeframe: From randomization till 28 weeks after randomization.Population: intention to treat (ITT) population
Short-time efficacy of disease activity based on a swollen and tender joint count of 28 joints and C-reactive proteine (scale range 0.0 to 9.4; remission: value below 2.6; low disease activity: from 2.6 till 3.2 (included); moderate disease activity: above 3.2 till 5.1; high disease activity: above 5.1).
Outcome measures
| Measure |
Standard COBRA-Slim Induction
n=55 Participants
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme
|
COBRA-Slim Bio-induction
n=55 Participants
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
|
|---|---|---|
|
Proportion of Insufficient Responders Achieving Remission (DAS28CRP<2.6) 28 Weeks After Randomization (Short Term Efficacy) to Either COBRA-Slim Bio-Induction or Standard COBRA-Slim Induction
|
24 participants
Interval 17.0 to 32.0
|
32 participants
Interval 24.0 to 40.0
|
SECONDARY outcome
Timeframe: at week 104Population: intention to treat (ITT) population
Short-time efficacy of disease activity based on a swollen and tender joint count of 28 joints and C-reactive proteine (scale range 0.0 to 9.4; remission: value below 2.6; low disease activity: from 2.6 till 3.2 (included); moderate disease activity: above 3.2 till 5.1; high disease activity: above 5.1).
Outcome measures
| Measure |
Standard COBRA-Slim Induction
n=55 Participants
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme
|
COBRA-Slim Bio-induction
n=55 Participants
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
|
|---|---|---|
|
Proportion of Patients in Remission Defined as DAS28CRP<2.6
|
38 participants
Interval 30.0 to 44.0
|
30 participants
Interval 22.0 to 37.0
|
SECONDARY outcome
Timeframe: at 28 weeks after randomizationPopulation: Intention to treat (ITT) population
proportion of patients achieving a EULAR response, based on actual disease activity on a tender/swollen joint count and C-reactive proteine (DAS28-CRP) 28 weeks after randomization and improvement in DAS28-CRP from baseline. The EULAR response criteria classify patients as good, moderate or non-responders, using the individual amount of change in the DAS28-CRP and the DAS28-CRP value (low, moderate, or high) reached according to the following tabel: DAS28-CRP at endpoint improvement in DAS28-CRP from baseline \<=1,2 \>0,6 and \<= 1,2 \<=0,6 \<= 3,2 good moderate none \>3,2 and \<= 5,1 moderate moderate none \>5,1 moderate none none Additionally all patients with a good response were also included in the number of participants with at least a moderate response.
Outcome measures
| Measure |
Standard COBRA-Slim Induction
n=55 Participants
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme
|
COBRA-Slim Bio-induction
n=55 Participants
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
|
|---|---|---|
|
Proportion of Patients Achieving a EULAR Response
Good Response
|
26 participants
Interval 18.0 to 34.0
|
25 participants
Interval 18.0 to 33.0
|
|
Proportion of Patients Achieving a EULAR Response
Moderate Response
|
41 participants
Interval 32.0 to 47.0
|
40 participants
Interval 32.0 to 46.0
|
SECONDARY outcome
Timeframe: at week 104Population: Intention to treat (ITT) population
proportion of patients achieving a EULAR response, based on actual disease activity on a tender/swollen joint count and C-reactive proteine (DAS28-CRP) at week 104 and improvement in DAS28-CRP from baseline. The EULAR response criteria classify patients as good, moderate or non-responders, using the individual amount of change in the DAS28-CRP and the DAS28-CRP value (low, moderate, or high) reached according to the following tabel: DAS28-CRP at endpoint improvement in DAS28-CRP from baseline \<=1,2 \>0,6 and \<= 1,2 \<=0,6 \<= 3,2 good moderate none \>3,2 and \<= 5,1 moderate moderate none \>5,1 moderate none none Additionally all patients with a good response were also included in the number of participants with at least a moderate response.
Outcome measures
| Measure |
Standard COBRA-Slim Induction
n=55 Participants
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme
|
COBRA-Slim Bio-induction
n=55 Participants
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
|
|---|---|---|
|
Proportion of Patients Achieving a EULAR Response
Good Response
|
42 participants
Interval 35.0 to 48.0
|
34 participants
Interval 26.0 to 41.0
|
|
Proportion of Patients Achieving a EULAR Response
Moderate Response
|
52 participants
Interval 45.0 to 54.0
|
49 participants
Interval 42.0 to 52.0
|
SECONDARY outcome
Timeframe: at 28 weeks after randomizationPopulation: Intention to treat (ITT) population
HAQ measures physical function as reported by the patient, total score range from 0-3 of which higher scores represent worse physical function.
Outcome measures
| Measure |
Standard COBRA-Slim Induction
n=55 Participants
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme
|
COBRA-Slim Bio-induction
n=55 Participants
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
|
|---|---|---|
|
Health Assessment Questionnaire (HAQ) Response
|
0.7 score on a scale
Standard Deviation 0.7
|
0.8 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: at week 104Population: Intention to treat (ITT) population
HAQ measures physical function as reported by the patient, total score range from 0-3 of which higher scores represent worse physical function.
Outcome measures
| Measure |
Standard COBRA-Slim Induction
n=55 Participants
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme
|
COBRA-Slim Bio-induction
n=55 Participants
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
|
|---|---|---|
|
Health Assessment Questionnaire (HAQ) Response
|
0.7 score on a scale
Standard Deviation 0.7
|
0.9 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: at week 52Population: Intention to treat (ITT) population
Radiographic progression at week 52 is scored according to the Sharp-Van der Heijde score (SvdH). The SvdH method scores the presence of erosions in 16 joints of hands and wrists (graded from 0 to 5), and in 6 joints of the feet (graded from 0 to 10), and the presence of joint space narrowing in 15 joints of the hands and wrists (graded from 0 to 4) and in 6 joints of the feet (graded from 0 to 4). The maximal range is 280 units for erosion and 168 units for joint space narrowing, summing up to 448 units for the total score. The progression is calculated by subtracting the total score at week 52 minus the total score at baseline (ranging from 0 to 448) Higher values in each (sub) scale represents a worse outcome.
Outcome measures
| Measure |
Standard COBRA-Slim Induction
n=55 Participants
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme
|
COBRA-Slim Bio-induction
n=55 Participants
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
|
|---|---|---|
|
Radiographic Progression
|
0.5 units on a scale
Standard Deviation 1.2
|
0.3 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: at week 104Population: Intention to treat (ITT) population.
Radiographic progression at week 104 is scored according to the Sharp-Van der Heijde score (SvdH). The SvdH method scores the presence of erosions in 16 joints of hands and wrists (graded from 0 to 5), and in 6 joints of the feet (graded from 0 to 10), and the presence of joint space narrowing in 15 joints of the hands and wrists (graded from 0 to 4) and in 6 joints of the feet (graded from 0 to 4). The maximal range is 280 units for erosion and 168 units for joint space narrowing, summing up to 448 units for the total score. The progression is calculated by subtracting the total score at week 104 minus the total score at baseline (ranging from 0 to 448) Higher values in each (sub) scale represents a worse outcome.
Outcome measures
| Measure |
Standard COBRA-Slim Induction
n=55 Participants
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme
|
COBRA-Slim Bio-induction
n=55 Participants
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
|
|---|---|---|
|
Radiographic Progression
|
0.7 units on a scale
Standard Deviation 2.1
|
0.8 units on a scale
Standard Deviation 1.7
|
Adverse Events
Standard COBRA-Slim Induction
Serious events: 4 serious events
Other events: 43 other events
Deaths: 1 deaths
COBRA-Slim Bio-induction
Serious events: 5 serious events
Other events: 47 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Standard COBRA-Slim Induction
n=55 participants at risk
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme
|
COBRA-Slim Bio-induction
n=55 participants at risk
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
|
|---|---|---|
|
Vascular disorders
aortic dissection
|
0.00%
0/55 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
1.8%
1/55 • Number of events 1 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Cardiac disorders
myocardial ischaemia
|
1.8%
1/55 • Number of events 1 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
0.00%
0/55 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Cardiac disorders
stress cardiomyopathy
|
1.8%
1/55 • Number of events 1 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
0.00%
0/55 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Nervous system disorders
cerobrovascular accident
|
1.8%
1/55 • Number of events 1 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
0.00%
0/55 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Blood and lymphatic system disorders
leukopenia
|
1.8%
1/55 • Number of events 1 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
0.00%
0/55 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Skin and subcutaneous tissue disorders
erythema multiforme
|
1.8%
1/55 • Number of events 1 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
0.00%
0/55 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Psychiatric disorders
psychiatric decompensation
|
0.00%
0/55 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
1.8%
1/55 • Number of events 1 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Musculoskeletal and connective tissue disorders
bursitis
|
0.00%
0/55 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
1.8%
1/55 • Number of events 1 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Infections and infestations
enterococcal sepsis
|
0.00%
0/55 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
1.8%
1/55 • Number of events 1 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Infections and infestations
respiratory tract infection
|
0.00%
0/55 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
1.8%
1/55 • Number of events 1 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
Other adverse events
| Measure |
Standard COBRA-Slim Induction
n=55 participants at risk
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG): Leflunomide 10mg PO daily added to the COBRA-Slim scheme
|
COBRA-Slim Bio-induction
n=55 participants at risk
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML: Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
|
|---|---|---|
|
General disorders
fatigue
|
21.8%
12/55 • Number of events 12 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
23.6%
13/55 • Number of events 13 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
General disorders
injection site erythema
|
1.8%
1/55 • Number of events 1 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
5.5%
3/55 • Number of events 3 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
General disorders
pyrexia
|
0.00%
0/55 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
7.3%
4/55 • Number of events 5 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Cardiac disorders
palpitations
|
0.00%
0/55 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
7.3%
4/55 • Number of events 4 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Nervous system disorders
headache
|
1.8%
1/55 • Number of events 1 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
5.5%
3/55 • Number of events 4 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Gastrointestinal disorders
nausea
|
14.5%
8/55 • Number of events 11 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
25.5%
14/55 • Number of events 17 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Gastrointestinal disorders
abdominal discomfort
|
9.1%
5/55 • Number of events 5 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
10.9%
6/55 • Number of events 6 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Gastrointestinal disorders
diarrhoea
|
18.2%
10/55 • Number of events 11 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
10.9%
6/55 • Number of events 7 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Gastrointestinal disorders
abdominal pain upper
|
7.3%
4/55 • Number of events 4 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
7.3%
4/55 • Number of events 5 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
0.00%
0/55 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
5.5%
3/55 • Number of events 3 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Gastrointestinal disorders
dyspepsia
|
5.5%
3/55 • Number of events 3 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
3.6%
2/55 • Number of events 2 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Hepatobiliary disorders
hepatic function abnormal
|
25.5%
14/55 • Number of events 18 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
16.4%
9/55 • Number of events 12 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Skin and subcutaneous tissue disorders
alopecia
|
10.9%
6/55 • Number of events 6 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
10.9%
6/55 • Number of events 6 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Skin and subcutaneous tissue disorders
acne
|
5.5%
3/55 • Number of events 4 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
1.8%
1/55 • Number of events 1 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
5.5%
3/55 • Number of events 3 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
1.8%
1/55 • Number of events 2 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Infections and infestations
nasopharyngitis
|
7.3%
4/55 • Number of events 4 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
5.5%
3/55 • Number of events 4 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Infections and infestations
COVID-19
|
3.6%
2/55 • Number of events 2 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
10.9%
6/55 • Number of events 6 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
|
Infections and infestations
bronchitis
|
5.5%
3/55 • Number of events 4 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
1.8%
1/55 • Number of events 2 • (Serious) adverse reactions or events of interest are collected over the duration of the trial e.g. 2 years (from screening till w104)
In the CareRA2020 trial, only (serious) events related to rheumatoid arthritis (RA), the RA treatment, or in case of an event of special interest (as specified in the protocol and including deaths) are to be reported according to the protocol. Collection of these reactions was done by delegated study staff questioning the patient at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution/PI may only publish the Results provided that Sponsor has duly published the main Study publication. Once the main Study publication has been duly published by the Sponsor, Institution/PI are entitled to publish the Results provided that Sponsor has granted its prior written approval with Institution's/PI's proposed publication. If SPONSOR did not respond within 90 days, the institution/PI may proceed with the publication.
- Publication restrictions are in place
Restriction type: OTHER