Trial · NCT03649061
COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA
NCT03649061, Phase 4, Completed, P. Verschueren; results first posted 2025-06-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA. Trials, record NCT03649061. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03649061
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA
- NCT number
- NCT03649061
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 276 participants, actual
- Lead sponsor
- P. Verschueren
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Etanercept 50 MG/ML, Leflunomide 10 milligram (MG)
- First posted
- 2018-08-28
- Last updated
- 2025-06-19
- Other registries' IDs
- eudract:2017-004054-41
- Results first posted
- 2025-06-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under Curve (AUC) of Disease Activity Score Based on a 28 Jointcount and C-reactive Protein (DAS28CRP) | baseline, w4, w8, w16, w24, w32, w40, w52, w64, w78, w92 and w104 | 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 |
| Secondary | 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 | From randomization till 28 weeks after randomization. | 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). |
| Secondary | Proportion of Patients in Remission Defined as DAS28CRP<2.6 | at week 104 | 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). |
| Secondary | Proportion of Patients Achieving a EULAR Response | at 28 weeks after randomization | 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. |
| Secondary | Proportion of Patients Achieving a EULAR Response | at week 104 | 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. |
| Secondary | Health Assessment Questionnaire (HAQ) Response | at 28 weeks after randomization | HAQ measures physical function as reported by the patient, total score range from 0-3 of which higher scores represent worse physical function. |
| Secondary | Health Assessment Questionnaire (HAQ) Response | at week 104 | HAQ measures physical function as reported by the patient, total score range from 0-3 of which higher scores represent worse physical function. |
| Secondary | Radiographic Progression | at week 52 | 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. |
| Secondary | Radiographic Progression | at week 104 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under Curve (AUC) of Disease Activity Score Based on a 28 Jointcount and C-reactive Protein (DAS28CRP) | baseline, w4, w8, w16, w24, w32, w40, w52, w64, w78, w92 and w104 | intention to treat (ITT) population | units on a scale*week | MEAN |
| SECONDARY | 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 | From randomization till 28 weeks after randomization. | intention to treat (ITT) population | participants | NUMBER |
| SECONDARY | Proportion of Patients in Remission Defined as DAS28CRP<2.6 | at week 104 | intention to treat (ITT) population | participants | NUMBER |
| SECONDARY | Proportion of Patients Achieving a EULAR Response | at 28 weeks after randomization | Intention to treat (ITT) population | participants | NUMBER |
| SECONDARY | Proportion of Patients Achieving a EULAR Response | at week 104 | Intention to treat (ITT) population | participants | NUMBER |
| SECONDARY | Health Assessment Questionnaire (HAQ) Response | at 28 weeks after randomization | Intention to treat (ITT) population | score on a scale | MEAN |
| SECONDARY | Health Assessment Questionnaire (HAQ) Response | at week 104 | Intention to treat (ITT) population | score on a scale | MEAN |
| SECONDARY | Radiographic Progression | at week 52 | Intention to treat (ITT) population | units on a scale | MEAN |
| SECONDARY | Radiographic Progression | at week 104 | Intention to treat (ITT) population. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under Curve (AUC) of Disease Activity Score Based on a 28 Jointcount and C-reactive Protein (DAS28CRP) | Standard COBRA-Slim Induction | 297.4 | 95% Confidence Interval 277.1 to 317.7 | units on a scale*week | |
| Area Under Curve (AUC) of Disease Activity Score Based on a 28 Jointcount and C-reactive Protein (DAS28CRP) | COBRA-Slim Bio-induction | 300.7 | 95% Confidence Interval 282.3 to 319.1 | units on a scale*week | |
| 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 | Standard COBRA-Slim Induction | 24 | 95% Confidence Interval 17 to 32 | participants | |
| 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 | COBRA-Slim Bio-induction | 32 | 95% Confidence Interval 24 to 40 | participants | |
| Proportion of Patients in Remission Defined as DAS28CRP<2.6 | Standard COBRA-Slim Induction | 38 | 95% Confidence Interval 30 to 44 | participants | |
| Proportion of Patients in Remission Defined as DAS28CRP<2.6 | COBRA-Slim Bio-induction | 30 | 95% Confidence Interval 22 to 37 | participants | |
| Proportion of Patients Achieving a EULAR Response | Standard COBRA-Slim Induction | Good Response | 26 | 95% Confidence Interval 18 to 34 | participants |
| Proportion of Patients Achieving a EULAR Response | COBRA-Slim Bio-induction | Good Response | 25 | 95% Confidence Interval 18 to 33 | participants |
| Proportion of Patients Achieving a EULAR Response | Standard COBRA-Slim Induction | Moderate Response | 41 | 95% Confidence Interval 32 to 47 | participants |
| Proportion of Patients Achieving a EULAR Response | COBRA-Slim Bio-induction | Moderate Response | 40 | 95% Confidence Interval 32 to 46 | participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard COBRA-Slim Induction | 55 | |
| Overall Study | STARTED | COBRA-Slim Bio-induction | 55 | |
| Overall Study | COMPLETED | Standard COBRA-Slim Induction | 46 | |
| Overall Study | COMPLETED | COBRA-Slim Bio-induction | 46 | |
| Overall Study | NOT COMPLETED | Standard COBRA-Slim Induction | 9 | |
| Overall Study | NOT COMPLETED | COBRA-Slim Bio-induction | 9 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | fatigue | General disorders | Standard COBRA-Slim Induction | 12 | 55 | 12 |
| other | fatigue | General disorders | COBRA-Slim Bio-induction | 13 | 55 | 13 |
| other | injection site erythema | General disorders | Standard COBRA-Slim Induction | 1 | 55 | 1 |
| other | injection site erythema | General disorders | COBRA-Slim Bio-induction | 3 | 55 | 3 |
| other | pyrexia | General disorders | Standard COBRA-Slim Induction | 0 | 55 | 0 |
| other | pyrexia | General disorders | COBRA-Slim Bio-induction | 4 | 55 | 5 |
| other | palpitations | Cardiac disorders | Standard COBRA-Slim Induction | 0 | 55 | 0 |
| other | palpitations | Cardiac disorders | COBRA-Slim Bio-induction | 4 | 55 | 4 |
| other | headache | Nervous system disorders | Standard COBRA-Slim Induction | 1 | 55 | 1 |
| other | headache | Nervous system disorders | COBRA-Slim Bio-induction | 3 | 55 | 4 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard COBRA-Slim Induction | 1 | 55 |
| Total, all-cause mortality | COBRA-Slim Bio-induction | 1 | 55 |
| Total, other adverse events | Standard COBRA-Slim Induction | 43 | 55 |
| Total, other adverse events | COBRA-Slim Bio-induction | 47 | 55 |
| Total, serious adverse events | Standard COBRA-Slim Induction | 4 | 55 |
| Total, serious adverse events | COBRA-Slim Bio-induction | 5 | 55 |
Source ClinicalTrials.gov
Papers14
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard COBRA-Slim Induction vs COBRA-Slim Bio-induction: Proportion of Patients in Remission Defined as DAS28CRP<2.6 | Trial comparisons |
Standard COBRA-Slim Induction vs COBRA-Slim Bio-induction: 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 | Trial comparisons |
| Standard COBRA-Slim Induction vs COBRA-Slim Bio-induction: deaths from any cause | Trial comparisons |
| Standard COBRA-Slim Induction vs COBRA-Slim Bio-induction: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03649061
GET https://conductscience.org/api/trials/v1/NCT03649061/results?page=2