Trial Outcomes & Findings for A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (NCT NCT02167139)
NCT ID: NCT02167139
Last Updated: 2017-08-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
544 participants
Primary outcome timeframe
Week 24
Results posted on
2017-08-17
Participant Flow
Participant milestones
| Measure |
SB5 (Proposed Biosimilar to Adalimumab)
SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
|
Humira (Adalimumab)
Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
|
Humira (Adalimumab), Switch to SB5
From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
|
Humira (Adalimumab), Continue as Humira
From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
|
|---|---|---|---|---|
|
Randomised, Double-blind
STARTED
|
271
|
273
|
0
|
0
|
|
Randomised, Double-blind
COMPLETED
|
254
|
254
|
0
|
0
|
|
Randomised, Double-blind
NOT COMPLETED
|
17
|
19
|
0
|
0
|
|
Transition-extension
STARTED
|
254
|
0
|
125
|
129
|
|
Transition-extension
COMPLETED
|
248
|
0
|
117
|
124
|
|
Transition-extension
NOT COMPLETED
|
6
|
0
|
8
|
5
|
Reasons for withdrawal
| Measure |
SB5 (Proposed Biosimilar to Adalimumab)
SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
|
Humira (Adalimumab)
Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
|
Humira (Adalimumab), Switch to SB5
From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
|
Humira (Adalimumab), Continue as Humira
From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
|
|---|---|---|---|---|
|
Randomised, Double-blind
Other
|
3
|
0
|
0
|
0
|
|
Randomised, Double-blind
Withdrawal by Subject
|
11
|
8
|
0
|
0
|
|
Randomised, Double-blind
Adverse Event
|
2
|
9
|
0
|
0
|
|
Randomised, Double-blind
Lack of Efficacy
|
1
|
2
|
0
|
0
|
|
Transition-extension
Adverse Event
|
2
|
0
|
2
|
3
|
|
Transition-extension
Withdrawal by Subject
|
2
|
0
|
4
|
1
|
|
Transition-extension
Lack of Efficacy
|
0
|
0
|
1
|
1
|
|
Transition-extension
Other
|
1
|
0
|
1
|
0
|
|
Transition-extension
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Baseline characteristics by cohort
| Measure |
SB5 (Proposed Biosimilar to Adalimumab)
n=271 Participants
SB5 40 mg every other week via subcutaneous injection
SB5 (proposed biosimilar to adalimumab)
|
Humira (Adalimumab)
n=273 Participants
Humira 40 mg every other week via subcutaneous injection
Humira (adalimumab)
SB5 (proposed biosimilar to adalimumab)
|
Total
n=544 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 12.67 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 11.91 • n=7 Participants
|
51.2 years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
217 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
441 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Outcome measures
| Measure |
SB5 (Proposed Biosimilar to Adalimumab)
n=239 Participants
SB5 40 mg every other week via subcutaneous injection up to Week 24
|
Humira (Adalimumab)
n=237 Participants
Humira 40 mg every other week via subcutaneous injection up to Week 24
|
Humira (Adalimumab), Continue as Humira
From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
|
Humira (Adalimumab), Switch to SB5 at Week 52
From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
|
Humira (Adalimumab), Continue as Humira at Week 52
From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
|
|---|---|---|---|---|---|
|
American College of Rheumatology 20% Response Criteria (ACR20)
|
72.4 percentage of participants
|
72.2 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Outcome measures
| Measure |
SB5 (Proposed Biosimilar to Adalimumab)
n=212 Participants
SB5 40 mg every other week via subcutaneous injection up to Week 24
|
Humira (Adalimumab)
n=106 Participants
Humira 40 mg every other week via subcutaneous injection up to Week 24
|
Humira (Adalimumab), Continue as Humira
n=111 Participants
From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
|
Humira (Adalimumab), Switch to SB5 at Week 52
From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
|
Humira (Adalimumab), Continue as Humira at Week 52
From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
|
|---|---|---|---|---|---|
|
ACR20
|
76.9 percentage of participants
|
81.1 percentage of participants
|
71.2 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24, Week 52Outcome measures
| Measure |
SB5 (Proposed Biosimilar to Adalimumab)
n=239 Participants
SB5 40 mg every other week via subcutaneous injection up to Week 24
|
Humira (Adalimumab)
n=237 Participants
Humira 40 mg every other week via subcutaneous injection up to Week 24
|
Humira (Adalimumab), Continue as Humira
n=212 Participants
From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
|
Humira (Adalimumab), Switch to SB5 at Week 52
n=106 Participants
From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
|
Humira (Adalimumab), Continue as Humira at Week 52
n=111 Participants
From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
|
|---|---|---|---|---|---|
|
American College of Rheumatology 50% Response Criteria (ACR50)
|
38.1 percentage of participants
|
39.7 percentage of participants
|
49.1 percentage of participants
|
53.8 percentage of participants
|
51.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24, Week 52Outcome measures
Outcome data not reported
Adverse Events
SB5 (Proposed Biosimilar to Adalimumab)
Serious events: 9 serious events
Other events: 35 other events
Deaths: 0 deaths
Humira (Adalimumab)
Serious events: 16 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB5 (Proposed Biosimilar to Adalimumab)
n=268 participants at risk
SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
|
Humira (Adalimumab)
n=273 participants at risk
Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
|
|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.37%
1/268 • Number of events 1
|
0.00%
0/273
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Eye disorders
Retinal oedema
|
0.37%
1/268 • Number of events 1
|
0.00%
0/273
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.37%
1/268 • Number of events 1
|
0.00%
0/273
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.37%
1/268 • Number of events 1
|
0.00%
0/273
|
|
Infections and infestations
Viral infection
|
0.37%
1/268 • Number of events 1
|
0.00%
0/273
|
|
Infections and infestations
Bronchitis
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/268
|
0.73%
2/273 • Number of events 2
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.37%
1/268 • Number of events 1
|
0.37%
1/273 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.37%
1/268 • Number of events 1
|
0.00%
0/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Nervous system disorders
Lumber radiculopathy
|
0.37%
1/268 • Number of events 1
|
0.00%
0/273
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.37%
1/268 • Number of events 1
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/268
|
0.37%
1/273 • Number of events 1
|
Other adverse events
| Measure |
SB5 (Proposed Biosimilar to Adalimumab)
n=268 participants at risk
SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
|
Humira (Adalimumab)
n=273 participants at risk
Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.0%
24/268 • Number of events 27
|
11.0%
30/273 • Number of events 34
|
|
Nervous system disorders
Headache
|
4.1%
11/268 • Number of events 13
|
5.1%
14/273 • Number of events 15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them.
- Publication restrictions are in place
Restriction type: OTHER