Trial Outcomes & Findings for Rituximab (RTX) Therapy in Patients With Active TAO (NCT NCT02378298)
NCT ID: NCT02378298
Last Updated: 2025-03-26
Results Overview
Clinical activity score (CAS) according to Mouritz et al and the consensus statement from European Group of Graves orbitopathy (EUGOGO). It consists of 10 items (1. Spontaneous retrobulbar pain, 2. Pain on eye movements, 3. Eyelid erythema, 4. Conjunctival injection, 5. Chemosis, 6. Swelling of the caruncle, 7. Eyelid edema or fullness, 8. Change in motility,9. Change in vision acuity,10.Change in proptosis). One point is given to each item, if present. CAS is the sum of single scores, ranging from 0 (no activity) to 10 (maximal activity).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
38 participants
Primary outcome timeframe
At 4,12,18 and 68 weeks
Results posted on
2025-03-26
Participant Flow
The Enrollment number in the Protocol Section (38) conflicts with the number of participants Started in the Participant Flow module (37). The allocation to the groups (NR-RTX or R-GC) depends on the assessment of the participants' response AT 4 WEEKS. Since one participant dropped-out during the run-in period, i.e. BEFORE the evaluation at 4 weeks, this participant was NOT assigned to an Arm/Group during the Run-In period and can therefore not be included in results reported in a tabular format.
Participant milestones
| Measure |
Responders (R-CG)
All patients in the study have a 4 weeks period of 500 mg methylprednisolone iv/week. Depending of the response patients are classified as non- responders (and are given RTX and MTX) or responders. The responders continue with intravenous infusion of Methylprednisolone 500 mg /week in 2 weeks and thereafter 250 mg iv/week in 6 weeks.
|
Non-responders RTX+MTX (NR-RTX)
Patients with moderate-severe TAO with an inflammatory CAS of ≥ 4 that do not respond to iv GC (deltaCAS \<2 compared to baseline after 4 weeks of iv GC ) or do relapse (deltaCAS ≥2 and total CAS ≥4) after steroid treatment compared to previous CAS measurement at 12 weeks. Rituximab (1000 mg iv with 2 weeks in between) is combined with methotrexate (15-20 mg once a week) to minimize the risk of antibody developement. MTX is always combined with RTX and is never given as a monotherapy in this study.
rituximab and methotrexate
|
Non-responders Control Group (R-C)
A retrospective group of non-responsive patients after 4 weeks with iv glucocorticoids, who received regular care, i.e. full 12-week treatment with glucocorticoids according to clinical praxis. This group was used as control and received the same therapy as Responders (R-CG).
|
|---|---|---|---|
|
Run-In (0-4 Weeks)
STARTED
|
13
|
12
|
12
|
|
Run-In (0-4 Weeks)
COMPLETED
|
13
|
10
|
12
|
|
Run-In (0-4 Weeks)
NOT COMPLETED
|
0
|
2
|
0
|
|
Intervention (5-12 Weeks)
STARTED
|
13
|
10
|
12
|
|
Intervention (5-12 Weeks)
COMPLETED
|
13
|
10
|
11
|
|
Intervention (5-12 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
|
Follow-up (13-18 Weeks)
STARTED
|
13
|
10
|
11
|
|
Follow-up (13-18 Weeks)
COMPLETED
|
13
|
10
|
11
|
|
Follow-up (13-18 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
|
Surveillance (19-68 Weeks)
STARTED
|
13
|
10
|
11
|
|
Surveillance (19-68 Weeks)
COMPLETED
|
12
|
10
|
11
|
|
Surveillance (19-68 Weeks)
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Responders (R-CG)
All patients in the study have a 4 weeks period of 500 mg methylprednisolone iv/week. Depending of the response patients are classified as non- responders (and are given RTX and MTX) or responders. The responders continue with intravenous infusion of Methylprednisolone 500 mg /week in 2 weeks and thereafter 250 mg iv/week in 6 weeks.
|
Non-responders RTX+MTX (NR-RTX)
Patients with moderate-severe TAO with an inflammatory CAS of ≥ 4 that do not respond to iv GC (deltaCAS \<2 compared to baseline after 4 weeks of iv GC ) or do relapse (deltaCAS ≥2 and total CAS ≥4) after steroid treatment compared to previous CAS measurement at 12 weeks. Rituximab (1000 mg iv with 2 weeks in between) is combined with methotrexate (15-20 mg once a week) to minimize the risk of antibody developement. MTX is always combined with RTX and is never given as a monotherapy in this study.
rituximab and methotrexate
|
Non-responders Control Group (R-C)
A retrospective group of non-responsive patients after 4 weeks with iv glucocorticoids, who received regular care, i.e. full 12-week treatment with glucocorticoids according to clinical praxis. This group was used as control and received the same therapy as Responders (R-CG).
|
|---|---|---|---|
|
Run-In (0-4 Weeks)
development of dysthyroid optic neuropathy
|
0
|
2
|
0
|
|
Intervention (5-12 Weeks)
As a deviation from the clinical praxis, withdrew the subject from the regular therapy
|
0
|
0
|
1
|
|
Surveillance (19-68 Weeks)
Death
|
1
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Non-responders RTX+MTX (NR-RTX)
n=12 Participants
Patients with moderate-severe TAO with an inflammatory CAS of ≥ 4 that do not respond to iv GC (deltaCAS \<2 compared to baseline after 4 weeks of iv GC ) or do relapse (deltaCAS ≥2 and total CAS ≥4) after steroid treatment compared to previous CAS measurement at 12 weeks. Rituximab (1000 mg iv with 2 weeks in between) is combined with methotrexate (15-20 mg once a week) to minimize the risk of antibody developement. MTX is always combined with RTX and is never given as a monotherapy in this study.
rituximab and methotrexate
|
Responders (R-CG)
n=13 Participants
All patients in the study have a 4 weeks period of 500 mg methylprednisolone iv/week. Depending of the response patients are classified as non- responders (and are given RTX and MTX) or responders. The responders continue with intravenous infusion of Methylprednisolone 500 mg /week in 2 weeks and thereafter 250 mg iv/week in 6 weeks.
|
Non-responders Control Group (R-C)
n=12 Participants
A retrospective group of non-responsive patients after 4 weeks with iv glucocorticoids, who received regular care, i.e. full 12-week treatment with glucocorticoids according to clinical praxis. This group was used as control and received the same therapy as Responders (R-CG).
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 9.1 • n=12 Participants
|
54.6 years
STANDARD_DEVIATION 6.9 • n=13 Participants
|
57.5 years
STANDARD_DEVIATION 12.0 • n=12 Participants
|
55 years
STANDARD_DEVIATION 9 • n=37 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=12 Participants
|
12 Participants
n=13 Participants
|
7 Participants
n=12 Participants
|
25 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=12 Participants
|
1 Participants
n=13 Participants
|
5 Participants
n=12 Participants
|
12 Participants
n=37 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Smoking status
Smoker
|
7 Participants
n=12 Participants • Missing data
|
2 Participants
n=13 Participants • Missing data
|
5 Participants
n=12 Participants • Missing data
|
14 Participants
n=37 Participants • Missing data
|
|
Smoking status
Previous smoker
|
4 Participants
n=12 Participants • Missing data
|
9 Participants
n=13 Participants • Missing data
|
2 Participants
n=12 Participants • Missing data
|
15 Participants
n=37 Participants • Missing data
|
|
Smoking status
Non-smoker
|
1 Participants
n=12 Participants • Missing data
|
2 Participants
n=13 Participants • Missing data
|
3 Participants
n=12 Participants • Missing data
|
6 Participants
n=37 Participants • Missing data
|
|
Smoking status
Unknown
|
0 Participants
n=12 Participants • Missing data
|
0 Participants
n=13 Participants • Missing data
|
2 Participants
n=12 Participants • Missing data
|
2 Participants
n=37 Participants • Missing data
|
|
Thyroid-stimulating hormone receptor antibodies
|
28.6 International Units per Liter
n=11 Participants • Blood sample missing.
|
11.4 International Units per Liter
n=11 Participants • Blood sample missing.
|
9.7 International Units per Liter
n=11 Participants • Blood sample missing.
|
11.4 International Units per Liter
n=33 Participants • Blood sample missing.
|
PRIMARY outcome
Timeframe: At 4,12,18 and 68 weeksClinical activity score (CAS) according to Mouritz et al and the consensus statement from European Group of Graves orbitopathy (EUGOGO). It consists of 10 items (1. Spontaneous retrobulbar pain, 2. Pain on eye movements, 3. Eyelid erythema, 4. Conjunctival injection, 5. Chemosis, 6. Swelling of the caruncle, 7. Eyelid edema or fullness, 8. Change in motility,9. Change in vision acuity,10.Change in proptosis). One point is given to each item, if present. CAS is the sum of single scores, ranging from 0 (no activity) to 10 (maximal activity).
Outcome measures
| Measure |
Non-responders RTX+MTX (NR-RTX)
n=12 Participants
Patients with moderate-severe TAO with an inflammatory CAS of ≥ 4 that do not respond to iv GC (deltaCAS \<2 compared to baseline after 4 weeks of iv GC ) or do relapse (deltaCAS ≥2 and total CAS ≥4) after steroid treatment compared to previous CAS measurement at 12 weeks. Rituximab (1000 mg iv with 2 weeks in between) is combined with methotrexate (15-20 mg once a week) to minimize the risk of antibody developement. MTX is always combined with RTX and is never given as a monotherapy in this study.
rituximab and methotrexate
|
Responders (R-CG)
n=13 Participants
All patients in the study have a 4 weeks period of 500 mg methylprednisolone iv/week. Depending of the response patients are classified as non- responders (and are given RTX and MTX) or responders. The responders continue with intravenous infusion of Methylprednisolone 500 mg /week in 2 weeks and thereafter 250 mg iv/week in 6 weeks.
|
Non-responders Control Group (R-C)
n=12 Participants
A retrospective group of non-responsive patients after 4 weeks with iv glucocorticoids, who received regular care, i.e. full 12-week treatment with glucocorticoids according to clinical praxis. This group was used as control and received the same therapy as Responders (R-CG).
|
|---|---|---|---|
|
Clinical Activity Score (a Composite Measure of Ophthalmological Signs and Symptoms)
at 4 weeks
|
4.25 score on a scale
Standard Deviation 0.99
|
2.77 score on a scale
Standard Deviation 1.36
|
4.25 score on a scale
Standard Deviation 0.87
|
|
Clinical Activity Score (a Composite Measure of Ophthalmological Signs and Symptoms)
at 12 weeks
|
4.20 score on a scale
Standard Deviation 1.03
|
2.88 score on a scale
Standard Deviation 1.33
|
4.00 score on a scale
Standard Deviation 1.41
|
|
Clinical Activity Score (a Composite Measure of Ophthalmological Signs and Symptoms)
at 18 weeks
|
4.05 score on a scale
Standard Deviation 1.23
|
3.81 score on a scale
Standard Deviation 1.35
|
3.63 score on a scale
Standard Deviation 1.60
|
|
Clinical Activity Score (a Composite Measure of Ophthalmological Signs and Symptoms)
at 68 weeks
|
3.00 score on a scale
Standard Deviation 1.39
|
2.58 score on a scale
Standard Deviation 1.40
|
2.14 score on a scale
Standard Deviation 2.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 4 weeksOutcome measures
| Measure |
Non-responders RTX+MTX (NR-RTX)
n=10 Participants
Patients with moderate-severe TAO with an inflammatory CAS of ≥ 4 that do not respond to iv GC (deltaCAS \<2 compared to baseline after 4 weeks of iv GC ) or do relapse (deltaCAS ≥2 and total CAS ≥4) after steroid treatment compared to previous CAS measurement at 12 weeks. Rituximab (1000 mg iv with 2 weeks in between) is combined with methotrexate (15-20 mg once a week) to minimize the risk of antibody developement. MTX is always combined with RTX and is never given as a monotherapy in this study.
rituximab and methotrexate
|
Responders (R-CG)
n=13 Participants
All patients in the study have a 4 weeks period of 500 mg methylprednisolone iv/week. Depending of the response patients are classified as non- responders (and are given RTX and MTX) or responders. The responders continue with intravenous infusion of Methylprednisolone 500 mg /week in 2 weeks and thereafter 250 mg iv/week in 6 weeks.
|
Non-responders Control Group (R-C)
n=5 Participants
A retrospective group of non-responsive patients after 4 weeks with iv glucocorticoids, who received regular care, i.e. full 12-week treatment with glucocorticoids according to clinical praxis. This group was used as control and received the same therapy as Responders (R-CG).
|
|---|---|---|---|
|
Thyroid-stimulating Hormone Receptor Antibodies
|
23.5 International Units per Liter
Interval 3.6 to 41.0
|
7.7 International Units per Liter
Interval 2.6 to 12.5
|
3.9 International Units per Liter
Interval 1.7 to 10.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at12 weeksOutcome measures
| Measure |
Non-responders RTX+MTX (NR-RTX)
n=10 Participants
Patients with moderate-severe TAO with an inflammatory CAS of ≥ 4 that do not respond to iv GC (deltaCAS \<2 compared to baseline after 4 weeks of iv GC ) or do relapse (deltaCAS ≥2 and total CAS ≥4) after steroid treatment compared to previous CAS measurement at 12 weeks. Rituximab (1000 mg iv with 2 weeks in between) is combined with methotrexate (15-20 mg once a week) to minimize the risk of antibody developement. MTX is always combined with RTX and is never given as a monotherapy in this study.
rituximab and methotrexate
|
Responders (R-CG)
n=12 Participants
All patients in the study have a 4 weeks period of 500 mg methylprednisolone iv/week. Depending of the response patients are classified as non- responders (and are given RTX and MTX) or responders. The responders continue with intravenous infusion of Methylprednisolone 500 mg /week in 2 weeks and thereafter 250 mg iv/week in 6 weeks.
|
Non-responders Control Group (R-C)
n=10 Participants
A retrospective group of non-responsive patients after 4 weeks with iv glucocorticoids, who received regular care, i.e. full 12-week treatment with glucocorticoids according to clinical praxis. This group was used as control and received the same therapy as Responders (R-CG).
|
|---|---|---|---|
|
Thyroid-stimulating Hormone Receptor Antibodies
|
15.0 International Units per Liter
Interval 1.8 to 32.8
|
2.1 International Units per Liter
Interval 0.8 to 4.4
|
8.1 International Units per Liter
Interval 1.5 to 20.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at18 weeksOutcome measures
| Measure |
Non-responders RTX+MTX (NR-RTX)
n=10 Participants
Patients with moderate-severe TAO with an inflammatory CAS of ≥ 4 that do not respond to iv GC (deltaCAS \<2 compared to baseline after 4 weeks of iv GC ) or do relapse (deltaCAS ≥2 and total CAS ≥4) after steroid treatment compared to previous CAS measurement at 12 weeks. Rituximab (1000 mg iv with 2 weeks in between) is combined with methotrexate (15-20 mg once a week) to minimize the risk of antibody developement. MTX is always combined with RTX and is never given as a monotherapy in this study.
rituximab and methotrexate
|
Responders (R-CG)
n=13 Participants
All patients in the study have a 4 weeks period of 500 mg methylprednisolone iv/week. Depending of the response patients are classified as non- responders (and are given RTX and MTX) or responders. The responders continue with intravenous infusion of Methylprednisolone 500 mg /week in 2 weeks and thereafter 250 mg iv/week in 6 weeks.
|
Non-responders Control Group (R-C)
n=4 Participants
A retrospective group of non-responsive patients after 4 weeks with iv glucocorticoids, who received regular care, i.e. full 12-week treatment with glucocorticoids according to clinical praxis. This group was used as control and received the same therapy as Responders (R-CG).
|
|---|---|---|---|
|
Thyroid-stimulating Hormone Receptor Antibodies
|
11.9 International Units per Liter
Interval 1.5 to 32.0
|
3.8 International Units per Liter
Interval 0.9 to 5.0
|
1.6 International Units per Liter
Interval 0.7 to 8.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 68 weeksOutcome measures
| Measure |
Non-responders RTX+MTX (NR-RTX)
n=9 Participants
Patients with moderate-severe TAO with an inflammatory CAS of ≥ 4 that do not respond to iv GC (deltaCAS \<2 compared to baseline after 4 weeks of iv GC ) or do relapse (deltaCAS ≥2 and total CAS ≥4) after steroid treatment compared to previous CAS measurement at 12 weeks. Rituximab (1000 mg iv with 2 weeks in between) is combined with methotrexate (15-20 mg once a week) to minimize the risk of antibody developement. MTX is always combined with RTX and is never given as a monotherapy in this study.
rituximab and methotrexate
|
Responders (R-CG)
n=9 Participants
All patients in the study have a 4 weeks period of 500 mg methylprednisolone iv/week. Depending of the response patients are classified as non- responders (and are given RTX and MTX) or responders. The responders continue with intravenous infusion of Methylprednisolone 500 mg /week in 2 weeks and thereafter 250 mg iv/week in 6 weeks.
|
Non-responders Control Group (R-C)
n=5 Participants
A retrospective group of non-responsive patients after 4 weeks with iv glucocorticoids, who received regular care, i.e. full 12-week treatment with glucocorticoids according to clinical praxis. This group was used as control and received the same therapy as Responders (R-CG).
|
|---|---|---|---|
|
Thyroid-stimulating Hormone Receptor Antibodies
|
1.9 International Units per Liter
Interval 0.7 to 22.0
|
2.1 International Units per Liter
Interval 0.7 to 11.0
|
4.0 International Units per Liter
Interval 0.7 to 9.1
|
Adverse Events
Non-responders RTX+MTX (NR-RTX)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Responders (R-CG)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Non-responders RTX+MTX (NR-RTX)
n=10 participants at risk
Patients with moderate-severe TAO with an inflammatory CAS of ≥ 4 that do not respond to iv GC (deltaCAS \<2 compared to baseline after 4 weeks of iv GC ) or do relapse (deltaCAS ≥2 and total CAS ≥4) after steroid treatment compared to previous CAS measurement at 12 weeks. Rituximab (1000 mg iv with 2 weeks in between) is combined with methotrexate (15-20 mg once a week) to minimize the risk of antibody developement. MTX is always combined with RTX and is never given as a monotherapy in this study.
rituximab and methotrexate
|
Responders (R-CG)
n=13 participants at risk
All patients in the study have a 4 weeks period of 500 mg methylprednisolone iv/week. Depending of the response patients are classified as non- responders (and are given RTX and MTX) or responders. The responders continue with intravenous infusion of Methylprednisolone 500 mg /week in 2 weeks and thereafter 250 mg iv/week in 6 weeks.
|
|---|---|---|
|
Nervous system disorders
Mental disorder
|
10.0%
1/10 • Number of events 1 • Intervention phase = 4-12 weeks Follow-up phase: 13-18 weeks Surveillance phase: 19-68 weeks
Data on Adverse events was collected only for the R-GC and NR-RTX during the 3 phases: intervention, follow-up \& surveillance. Data on adverse events was NOT collected during the run-in phase, ie. prior to start of the tested intervention Rituximab. During the run-in phase the participants received regular care according to clinical praxis. Data on adverse events was NOT collected from the NR-RC group, as the data related to this control group was collected retrospectively from medical journal.
|
0.00%
0/13 • Intervention phase = 4-12 weeks Follow-up phase: 13-18 weeks Surveillance phase: 19-68 weeks
Data on Adverse events was collected only for the R-GC and NR-RTX during the 3 phases: intervention, follow-up \& surveillance. Data on adverse events was NOT collected during the run-in phase, ie. prior to start of the tested intervention Rituximab. During the run-in phase the participants received regular care according to clinical praxis. Data on adverse events was NOT collected from the NR-RC group, as the data related to this control group was collected retrospectively from medical journal.
|
|
Nervous system disorders
Cerebral aneurysm
|
10.0%
1/10 • Number of events 2 • Intervention phase = 4-12 weeks Follow-up phase: 13-18 weeks Surveillance phase: 19-68 weeks
Data on Adverse events was collected only for the R-GC and NR-RTX during the 3 phases: intervention, follow-up \& surveillance. Data on adverse events was NOT collected during the run-in phase, ie. prior to start of the tested intervention Rituximab. During the run-in phase the participants received regular care according to clinical praxis. Data on adverse events was NOT collected from the NR-RC group, as the data related to this control group was collected retrospectively from medical journal.
|
0.00%
0/13 • Intervention phase = 4-12 weeks Follow-up phase: 13-18 weeks Surveillance phase: 19-68 weeks
Data on Adverse events was collected only for the R-GC and NR-RTX during the 3 phases: intervention, follow-up \& surveillance. Data on adverse events was NOT collected during the run-in phase, ie. prior to start of the tested intervention Rituximab. During the run-in phase the participants received regular care according to clinical praxis. Data on adverse events was NOT collected from the NR-RC group, as the data related to this control group was collected retrospectively from medical journal.
|
Other adverse events
| Measure |
Non-responders RTX+MTX (NR-RTX)
n=10 participants at risk
Patients with moderate-severe TAO with an inflammatory CAS of ≥ 4 that do not respond to iv GC (deltaCAS \<2 compared to baseline after 4 weeks of iv GC ) or do relapse (deltaCAS ≥2 and total CAS ≥4) after steroid treatment compared to previous CAS measurement at 12 weeks. Rituximab (1000 mg iv with 2 weeks in between) is combined with methotrexate (15-20 mg once a week) to minimize the risk of antibody developement. MTX is always combined with RTX and is never given as a monotherapy in this study.
rituximab and methotrexate
|
Responders (R-CG)
n=13 participants at risk
All patients in the study have a 4 weeks period of 500 mg methylprednisolone iv/week. Depending of the response patients are classified as non- responders (and are given RTX and MTX) or responders. The responders continue with intravenous infusion of Methylprednisolone 500 mg /week in 2 weeks and thereafter 250 mg iv/week in 6 weeks.
|
|---|---|---|
|
Cardiac disorders
High blood pressure
|
50.0%
5/10 • Number of events 7 • Intervention phase = 4-12 weeks Follow-up phase: 13-18 weeks Surveillance phase: 19-68 weeks
Data on Adverse events was collected only for the R-GC and NR-RTX during the 3 phases: intervention, follow-up \& surveillance. Data on adverse events was NOT collected during the run-in phase, ie. prior to start of the tested intervention Rituximab. During the run-in phase the participants received regular care according to clinical praxis. Data on adverse events was NOT collected from the NR-RC group, as the data related to this control group was collected retrospectively from medical journal.
|
53.8%
7/13 • Number of events 11 • Intervention phase = 4-12 weeks Follow-up phase: 13-18 weeks Surveillance phase: 19-68 weeks
Data on Adverse events was collected only for the R-GC and NR-RTX during the 3 phases: intervention, follow-up \& surveillance. Data on adverse events was NOT collected during the run-in phase, ie. prior to start of the tested intervention Rituximab. During the run-in phase the participants received regular care according to clinical praxis. Data on adverse events was NOT collected from the NR-RC group, as the data related to this control group was collected retrospectively from medical journal.
|
|
Hepatobiliary disorders
High liver tests
|
0.00%
0/10 • Intervention phase = 4-12 weeks Follow-up phase: 13-18 weeks Surveillance phase: 19-68 weeks
Data on Adverse events was collected only for the R-GC and NR-RTX during the 3 phases: intervention, follow-up \& surveillance. Data on adverse events was NOT collected during the run-in phase, ie. prior to start of the tested intervention Rituximab. During the run-in phase the participants received regular care according to clinical praxis. Data on adverse events was NOT collected from the NR-RC group, as the data related to this control group was collected retrospectively from medical journal.
|
7.7%
1/13 • Number of events 1 • Intervention phase = 4-12 weeks Follow-up phase: 13-18 weeks Surveillance phase: 19-68 weeks
Data on Adverse events was collected only for the R-GC and NR-RTX during the 3 phases: intervention, follow-up \& surveillance. Data on adverse events was NOT collected during the run-in phase, ie. prior to start of the tested intervention Rituximab. During the run-in phase the participants received regular care according to clinical praxis. Data on adverse events was NOT collected from the NR-RC group, as the data related to this control group was collected retrospectively from medical journal.
|
|
Endocrine disorders
Positive oral glucose tolerance test
|
30.0%
3/10 • Number of events 4 • Intervention phase = 4-12 weeks Follow-up phase: 13-18 weeks Surveillance phase: 19-68 weeks
Data on Adverse events was collected only for the R-GC and NR-RTX during the 3 phases: intervention, follow-up \& surveillance. Data on adverse events was NOT collected during the run-in phase, ie. prior to start of the tested intervention Rituximab. During the run-in phase the participants received regular care according to clinical praxis. Data on adverse events was NOT collected from the NR-RC group, as the data related to this control group was collected retrospectively from medical journal.
|
15.4%
2/13 • Number of events 4 • Intervention phase = 4-12 weeks Follow-up phase: 13-18 weeks Surveillance phase: 19-68 weeks
Data on Adverse events was collected only for the R-GC and NR-RTX during the 3 phases: intervention, follow-up \& surveillance. Data on adverse events was NOT collected during the run-in phase, ie. prior to start of the tested intervention Rituximab. During the run-in phase the participants received regular care according to clinical praxis. Data on adverse events was NOT collected from the NR-RC group, as the data related to this control group was collected retrospectively from medical journal.
|
|
Endocrine disorders
Inadequate response to short ACTH
|
0.00%
0/10 • Intervention phase = 4-12 weeks Follow-up phase: 13-18 weeks Surveillance phase: 19-68 weeks
Data on Adverse events was collected only for the R-GC and NR-RTX during the 3 phases: intervention, follow-up \& surveillance. Data on adverse events was NOT collected during the run-in phase, ie. prior to start of the tested intervention Rituximab. During the run-in phase the participants received regular care according to clinical praxis. Data on adverse events was NOT collected from the NR-RC group, as the data related to this control group was collected retrospectively from medical journal.
|
7.7%
1/13 • Number of events 1 • Intervention phase = 4-12 weeks Follow-up phase: 13-18 weeks Surveillance phase: 19-68 weeks
Data on Adverse events was collected only for the R-GC and NR-RTX during the 3 phases: intervention, follow-up \& surveillance. Data on adverse events was NOT collected during the run-in phase, ie. prior to start of the tested intervention Rituximab. During the run-in phase the participants received regular care according to clinical praxis. Data on adverse events was NOT collected from the NR-RC group, as the data related to this control group was collected retrospectively from medical journal.
|
Additional Information
Helena Filipsson Nyström
Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Göteborg
Phone: 0046-705833398
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place