Trial Outcomes & Findings for A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab (NCT NCT00808210)
NCT ID: NCT00808210
Last Updated: 2020-11-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Week 20
Results posted on
2020-11-06
Participant Flow
Participant milestones
| Measure |
Ocrelizumab 200mg
Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
|
Infliximab 5mg/kg
Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
|
|---|---|---|
|
Study Period + 48 Weeks of Follow-up
STARTED
|
15
|
13
|
|
Study Period + 48 Weeks of Follow-up
COMPLETED
|
6
|
4
|
|
Study Period + 48 Weeks of Follow-up
NOT COMPLETED
|
9
|
9
|
|
Double-Blind TX Period
STARTED
|
15
|
13
|
|
Double-Blind TX Period
COMPLETED
|
13
|
10
|
|
Double-Blind TX Period
NOT COMPLETED
|
2
|
3
|
|
Open Label Ocrelizumab Treatment Period
STARTED
|
9
|
4
|
|
Open Label Ocrelizumab Treatment Period
COMPLETED
|
0
|
0
|
|
Open Label Ocrelizumab Treatment Period
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
Ocrelizumab 200mg
Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
|
Infliximab 5mg/kg
Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
|
|---|---|---|
|
Study Period + 48 Weeks of Follow-up
Sponsor decision to terminate study
|
3
|
7
|
|
Study Period + 48 Weeks of Follow-up
Other reasons outside Sponsor decision
|
6
|
2
|
|
Double-Blind TX Period
Adverse Event
|
0
|
1
|
|
Double-Blind TX Period
Sponsor decision to terminate study
|
1
|
1
|
|
Double-Blind TX Period
Other reasons outside Sponsor decision
|
1
|
1
|
|
Open Label Ocrelizumab Treatment Period
Sponsor decision to terminate study
|
9
|
4
|
Baseline Characteristics
A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab
Baseline characteristics by cohort
| Measure |
Ocrelizumab 200mg
n=15 Participants
Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
|
Infliximab 5mg/kg
n=13 Participants
Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 Years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
54.2 Years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
53.83 Years
STANDARD_DEVIATION 13.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 20Population: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 30 monthsPopulation: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 30 monthsPopulation: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 30 monthsPopulation: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 30 monthsPopulation: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 30 monthsPopulation: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 30 monthsPopulation: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 30 monthsOutcome measures
| Measure |
Ocrelizumab 200mg
n=15 Participants
Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
|
Infliximab 5mg/kg
n=13 Participants
Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
78.9 Percentage of Participants
|
76.9 Percentage of Participants
|
Adverse Events
Ocrelizumab 200mg
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Infliximab 5mg/kg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ocrelizumab 200mg
n=19 participants at risk
Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
|
Infliximab 5mg/kg
n=13 participants at risk
Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Gastrointestinal disorders
ENTERITIS
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
HUMERUS FRACTURE
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
Other adverse events
| Measure |
Ocrelizumab 200mg
n=19 participants at risk
Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
|
Infliximab 5mg/kg
n=13 participants at risk
Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
|
|---|---|---|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTIOn
|
21.1%
4/19 • Number of events 4 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Infections and infestations
SINUSITIS
|
15.8%
3/19 • Number of events 3 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Infections and infestations
ALVEOLAR OSTEITIS
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Infections and infestations
BRONCHITIS
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Infections and infestations
HERPES ZOSTER
|
10.5%
2/19 • Number of events 2 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Infections and infestations
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Infections and infestations
ORAL INFECTION
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Infections and infestations
SKIN INFECTION
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Infections and infestations
TOOTH ABSCESS
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Gastrointestinal disorders
NAUSEA
|
10.5%
2/19 • Number of events 2 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
15.4%
2/13 • Number of events 2 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Gastrointestinal disorders
DIARRHOEA
|
10.5%
2/19 • Number of events 2 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Gastrointestinal disorders
VOMITING
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Gastrointestinal disorders
ENTERITIS
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
23.1%
3/13 • Number of events 3 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
FIBROMYALGIA
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Skin and subcutaneous tissue disorders
RASH
|
15.8%
3/19 • Number of events 3 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Skin and subcutaneous tissue disorders
COLD SWEAT
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Skin and subcutaneous tissue disorders
ROSACEA
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
General disorders
CHILLS
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
15.4%
2/13 • Number of events 2 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
General disorders
FATIGUE
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
General disorders
CHEST PAIN
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
15.4%
2/13 • Number of events 2 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Nervous system disorders
HEAD TITUBATION
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Investigations
HEART RATE INCREASED
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN NEOPLASM OF THYROID GLAND
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/19 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
7.7%
1/13 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Gastrointestinal disorders
TOOTHACHE
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
JOINT DISLOCATION
|
5.3%
1/19 • Number of events 1 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
0.00%
0/13 • Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER