Trial Outcomes & Findings for Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis (NCT NCT01955733)
NCT ID: NCT01955733
Last Updated: 2018-01-18
Results Overview
This outcome measure presents percentage of patients with drug related adverse events during the treatment phase. Treatment Emergent Adverse Events (TEAEs) were defined as Adverse Events (AEs) that started or worsened in severity on or after the first dose of trial medication in this extension study \[1301.4\] and prior to the last date of trial medication + 180 days \[inclusive\]. Drug-related events were those considered by the investigator to have a causal relationship to trial medication.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
91 participants
Primary outcome timeframe
Week 48
Results posted on
2018-01-18
Participant Flow
97 subjects were screened for eligibility to participate in this extension trial. 91 subjects met all inclusion and exclusion criteria and were assigned to receive treatment.
Participant milestones
| Measure |
BI 695500
The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.
Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
|
Rituxan From 1301.1
The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
MabThera From 1301.1
The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
|---|---|---|---|
|
Period 1
STARTED
|
33
|
29
|
29
|
|
Period 1
COMPLETED
|
32
|
29
|
29
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
0
|
|
Period 2
STARTED
|
32
|
29
|
29
|
|
Period 2
COMPLETED
|
20
|
10
|
8
|
|
Period 2
NOT COMPLETED
|
12
|
19
|
21
|
Reasons for withdrawal
| Measure |
BI 695500
The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.
Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
|
Rituxan From 1301.1
The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
MabThera From 1301.1
The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
|---|---|---|---|
|
Period 1
Lost to Follow-up
|
1
|
0
|
0
|
|
Period 2
Adverse Event
|
1
|
0
|
0
|
|
Period 2
Physician Decision
|
0
|
0
|
1
|
|
Period 2
Withdrawal by Subject
|
1
|
3
|
2
|
|
Period 2
Study terminated by sponsor
|
8
|
14
|
16
|
|
Period 2
Lost to Follow-up
|
2
|
0
|
0
|
|
Period 2
Other not defined above
|
0
|
2
|
2
|
Baseline Characteristics
Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
BI 695500
n=30 Participants
The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.
Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
|
Rituxan From 1301.1
n=29 Participants
The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
MabThera From 1301.1
n=29 Participants
The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.6 Years
STANDARD_DEVIATION 11.23 • n=5 Participants
|
56.3 Years
STANDARD_DEVIATION 11.02 • n=7 Participants
|
56.8 Years
STANDARD_DEVIATION 8.95 • n=5 Participants
|
55.9 Years
STANDARD_DEVIATION 10.38 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Safety Randomized Analysis Set (SAFRD): All subjects randomized in 1301.1 \[excluding open-label safety run-in subjects of trial 1301.1\] who receive at least one dose of trial medication and subjects will be classified according to treatment received in trial 1301.1. 2 subjects from 1301.1 safety run-in also received treatment in 1301.4, thus 88.
This outcome measure presents percentage of patients with drug related adverse events during the treatment phase. Treatment Emergent Adverse Events (TEAEs) were defined as Adverse Events (AEs) that started or worsened in severity on or after the first dose of trial medication in this extension study \[1301.4\] and prior to the last date of trial medication + 180 days \[inclusive\]. Drug-related events were those considered by the investigator to have a causal relationship to trial medication.
Outcome measures
| Measure |
BI 695500
n=30 Participants
The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.
Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
|
Rituxan From 1301.1
n=29 Participants
The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
MabThera From 1301.1
n=29 Participants
The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
|---|---|---|---|
|
The Percentage of Patients With Drug Related Adverse Events During the Treatment Phase
|
16.7 Percentage of patients
|
6.9 Percentage of patients
|
3.4 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.Population: The Full Analysis Set (FAS) consisted of all subjects from the randomised set of clinical trial 1301.1 who received at least one dose of trial medication and had data recorded for at least 1 DAS28 (ESR or C-reactive Protein \[CRP\]) or American College of Rheumatology 20% response criteria (ACR20).
DAS-28 (ESR)\*\* is an index containing a 28-joint count for tenderness (TJC28), 28 joint count for swelling (SJC28), natural logarithm of ESR (inflammation) (Ln\[ESR\]) and a general health component (GH) which is the patient's global assessment of disease activity and was used to describe the severity of RA. The DAS28 (ESR) Score is calculated as: DAS28(ESR) = 0.56\*√(TJC28) + 0.28\*√(SJC28) + 0.70\*ln(ESR) + 0.014\*(GH). DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. A clinically important change in DAS28 score is defined as an improvement in DAS28 score of at least 1.2. The mean change from baseline (in clinical trial 1301.1) at Week 48 in the DAS28 (ESR) score is presented.
Outcome measures
| Measure |
BI 695500
n=30 Participants
The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.
Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
|
Rituxan From 1301.1
n=26 Participants
The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
MabThera From 1301.1
n=28 Participants
The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
|---|---|---|---|
|
Change From Baseline in Clinical Trial 1301.1 in Disease Activity Score 28 (DAS28) (Erythrocyte Sedimentation Rate [ESR]) at Week 48 of Clinical Trial 1301.4
|
-2.0 Units on Scale
Interval -2.7 to -1.33
|
-2.0 Units on Scale
Interval -2.66 to -1.38
|
-1.6 Units on Scale
Interval -2.42 to -0.88
|
SECONDARY outcome
Timeframe: Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.Population: The FAS consisted of all subjects from the randomised set of clinical trial 1301.1 who received at least one dose of trial medication and had data recorded for at least 1 DAS28 (ESR or CRP) or ACR20.
A subject has an ACR20 response if all of the following occur: * a \> 20% improvement in the swollen joint count (66 joints) * a \> 20% improvement in the tender joint count (68 joints) * a \> 20% improvement in at least 3 of the following assessments: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index, or Acute phase reactant (CRP). The number of subjects meeting the ACR20 response criteria at Week 48 is presented.
Outcome measures
| Measure |
BI 695500
n=30 Participants
The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.
Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
|
Rituxan From 1301.1
n=26 Participants
The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
MabThera From 1301.1
n=28 Participants
The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
|---|---|---|---|
|
The Percentage of Patients Meeting the ACR20 [Based on Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4
|
3.7 Percentage of patients
|
4.3 Percentage of patients
|
4.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.Population: The FAS consisted of all patients from the randomised set of clinical trial 1301.1 who received at least one dose of trial medication and had data recorded for at least 1 DAS28 (ESR or CRP) or ACR20.
To meet the ACR/EULAR Remission criteria\*, the subject needed to satisfy the following criteria: * TCJ (68 joints) \< 1 * SJC (66 joints) \< 1 * CRP \< 1 milligrams per decilitre * patient global assessment \< 10. The patient global assessment for the definition of ACR/EULAR Remission was defined with a visual analog scale in millimetres (0-100).\*\* The number of subjects meeting the ACR/EULAR Remission definition at Week 48 is presented.
Outcome measures
| Measure |
BI 695500
n=30 Participants
The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.
Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
|
Rituxan From 1301.1
n=26 Participants
The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
MabThera From 1301.1
n=28 Participants
The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
|---|---|---|---|
|
The Percentage of Patients Who Meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Definition of Remission [Based on Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Week 48Population: FAS. Subjects who did not complete Week 48 are not presented.
This outcome measure presents percentage of patients who meet the EULAR response \[good response, moderate response, or no response\] \[based on DAS28 improvement since baseline in trial 1301.1\] at Week 48 of trial 1301.4.
Outcome measures
| Measure |
BI 695500
n=30 Participants
The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks.
Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
|
Rituxan From 1301.1
n=26 Participants
The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
MabThera From 1301.1
n=28 Participants
The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
|---|---|---|---|
|
The Percentage of Patients Who Meet the EULAR Response [Good Response, Moderate Response, or no Response] [Based on DAS28 Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4
No response
|
13.3 Percentage of patients
|
15.4 Percentage of patients
|
14.3 Percentage of patients
|
|
The Percentage of Patients Who Meet the EULAR Response [Good Response, Moderate Response, or no Response] [Based on DAS28 Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4
Good response
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
|
The Percentage of Patients Who Meet the EULAR Response [Good Response, Moderate Response, or no Response] [Based on DAS28 Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4
Moderate response
|
3.3 Percentage of patients
|
7.7 Percentage of patients
|
0.0 Percentage of patients
|
|
The Percentage of Patients Who Meet the EULAR Response [Good Response, Moderate Response, or no Response] [Based on DAS28 Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4
Missing
|
43.3 Percentage of patients
|
15.4 Percentage of patients
|
14.3 Percentage of patients
|
Adverse Events
BI 695500
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Rituxan From 1301.1
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
MabThera From 1301.1
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI 695500
n=30 participants at risk
The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks. Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
|
Rituxan From 1301.1
n=29 participants at risk
The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
MabThera From 1301.1
n=29 participants at risk
The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
0.00%
0/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
6.9%
2/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
3.4%
1/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
0.00%
0/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
0.00%
0/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
3.4%
1/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
0.00%
0/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
3.4%
1/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
|
Nervous system disorders
Cerebral microangiopathy
|
0.00%
0/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
3.4%
1/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
0.00%
0/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
0.00%
0/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
3.4%
1/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
3.4%
1/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
0.00%
0/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
3.4%
1/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
0.00%
0/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
Other adverse events
| Measure |
BI 695500
n=30 participants at risk
The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks. Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders.
|
Rituxan From 1301.1
n=29 participants at risk
The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
MabThera From 1301.1
n=29 participants at risk
The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later.
|
|---|---|---|---|
|
Infections and infestations
Sinusitis
|
3.3%
1/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
3.4%
1/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
6.9%
2/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
|
Infections and infestations
Urinary tract infection
|
10.0%
3/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
6.9%
2/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
13.8%
4/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
|
Infections and infestations
Viral upper respiratory tract infection
|
10.0%
3/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
6.9%
2/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
6.9%
2/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.3%
1/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
6.9%
2/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
3.4%
1/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
3.4%
1/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
0.00%
0/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
0.00%
0/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
6.9%
2/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/30 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
6.9%
2/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
0.00%
0/29 • TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER