Trial Outcomes & Findings for The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients (NCT NCT01163617)
NCT ID: NCT01163617
Last Updated: 2018-07-02
Results Overview
Participant's overall satisfaction of the injection was collected on a 10-cm visual analog scale (VAS) completed by participants immediately after self-injection. 0 = extremely unsatisfied, 10 = extremely satisfied.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
Phase A (Week 0 and Week 2)
Results posted on
2018-07-02
Participant Flow
One participant withdrew after Phase A and was replaced with a new participant prior to Phase B. Participants were re-randomized for Phase B.
Participant milestones
| Measure |
Current Syringe First, Then Physiolis Syringe
Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
|
Physiolis Syringe First, Then Current Syringe
Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)
|
Current Autoinjector First, Then Physiolis Autoinjector
Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
|
Physiolis Autoinjector First, Then Current Autoinjector
Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
|
Physiolis Autoinjector at 2° to 8°C
Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
|
Current Autoinjector 2° to 8°C
Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
|
Physiolis Autoinjector 20° to 27°C
Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
|
Current Autoinjector 20° to 27°C
Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
|
|---|---|---|---|---|---|---|---|---|
|
Phase A (User Experience), Weeks 0 and 2
STARTED
|
19
|
23
|
21
|
21
|
0
|
0
|
0
|
0
|
|
Phase A (User Experience), Weeks 0 and 2
COMPLETED
|
19
|
21
|
20
|
21
|
0
|
0
|
0
|
0
|
|
Phase A (User Experience), Weeks 0 and 2
NOT COMPLETED
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Phase B (Injection Time), Week 4
STARTED
|
0
|
0
|
0
|
0
|
18
|
27
|
16
|
20
|
|
Phase B (Injection Time), Week 4
COMPLETED
|
0
|
0
|
0
|
0
|
18
|
27
|
16
|
20
|
|
Phase B (Injection Time), Week 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Current Syringe First, Then Physiolis Syringe
Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
|
Physiolis Syringe First, Then Current Syringe
Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)
|
Current Autoinjector First, Then Physiolis Autoinjector
Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
|
Physiolis Autoinjector First, Then Current Autoinjector
Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
|
Physiolis Autoinjector at 2° to 8°C
Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
|
Current Autoinjector 2° to 8°C
Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
|
Physiolis Autoinjector 20° to 27°C
Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
|
Current Autoinjector 20° to 27°C
Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
|
|---|---|---|---|---|---|---|---|---|
|
Phase A (User Experience), Weeks 0 and 2
Withdrew consent
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase A (User Experience), Weeks 0 and 2
Failed to meet inclusion criteria
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase A (User Experience), Weeks 0 and 2
Didn't meet inclusion/exclusion criteria
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients
Baseline characteristics by cohort
| Measure |
All Study Participants
n=85 Participants
Includes participants from Phases A and B of the study
|
|---|---|
|
Age, Customized
<65 years
|
62 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
23 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Phase A (Week 0 and Week 2)Participant's overall satisfaction of the injection was collected on a 10-cm visual analog scale (VAS) completed by participants immediately after self-injection. 0 = extremely unsatisfied, 10 = extremely satisfied.
Outcome measures
| Measure |
Current/Physiolis Syringe
n=19 Participants
Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2)
|
Physiolis/Current Syringe
n=23 Participants
Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2)
|
Current/Physiolis Autoinjector
n=21 Participants
Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2)
|
Physiolis/Current Autoinjector
n=21 Participants
Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2)
|
|---|---|---|---|---|
|
Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector
Week 0
|
7.68 cm
Standard Deviation 2.97
|
8.71 cm
Standard Deviation 1.57
|
8.24 cm
Standard Deviation 1.82
|
8.62 cm
Standard Deviation 1.71
|
|
Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector
Week 2
|
8.47 cm
Standard Deviation 1.92
|
8.94 cm
Standard Deviation 1.51
|
7.63 cm
Standard Deviation 2.86
|
7.55 cm
Standard Deviation 2.71
|
PRIMARY outcome
Timeframe: Phase B (Week 4)A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible "click," until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C).
Outcome measures
| Measure |
Current/Physiolis Syringe
n=16 Participants
Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2)
|
Physiolis/Current Syringe
n=18 Participants
Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2)
|
Current/Physiolis Autoinjector
Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2)
|
Physiolis/Current Autoinjector
Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2)
|
|---|---|---|---|---|
|
Injection Duration for the Physiolis Autoinjector at Room Temperature (20° to 27°C) and at Storage Temperature (2° to 8°C) Compared to the Current Autoinjector Ejection Time Specification of Not More Than 10 Seconds
|
6.66 seconds
Interval 6.2 to 7.12
|
6.88 seconds
Interval 6.42 to 7.34
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase B (Week 4)A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible "click," until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C).
Outcome measures
| Measure |
Current/Physiolis Syringe
n=47 Participants
Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2)
|
Physiolis/Current Syringe
n=34 Participants
Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2)
|
Current/Physiolis Autoinjector
Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2)
|
Physiolis/Current Autoinjector
Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2)
|
|---|---|---|---|---|
|
Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector
|
6.88 seconds
Interval 5.85 to 7.9
|
6.78 seconds
Interval 6.46 to 7.09
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase B (Week 4)A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible "click," until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C).
Outcome measures
| Measure |
Current/Physiolis Syringe
n=20 Participants
Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2)
|
Physiolis/Current Syringe
n=27 Participants
Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2)
|
Current/Physiolis Autoinjector
Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2)
|
Physiolis/Current Autoinjector
Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2)
|
|---|---|---|---|---|
|
Injection Duration for the Current Autoinjector When Administered at Room Temperature (20° to 27°C) Versus the Storage Temperature (2° to 8°C)
|
6.32 seconds
Interval 4.35 to 8.29
|
7.29 seconds
Interval 6.16 to 8.42
|
—
|
—
|
Adverse Events
Current Syringe
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Physiolis Syringe
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Current Autoinjector
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Physiolis Autoinjector
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Physiolis Autoinjector at 2° to 8°C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Current Autoinjector 2° to 8°C
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Physiolis Autoinjector 20° to 27°C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Current Autoinjector 20° to 27°C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Current Syringe
n=40 participants at risk
Self-injection using current syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
|
Physiolis Syringe
n=42 participants at risk
Self-injection using Physiolis syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
|
Current Autoinjector
n=42 participants at risk
Self-injection using current autoinjector at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
|
Physiolis Autoinjector
n=41 participants at risk
Self-injection using Physiolis autoinjector at Week 0 or Week 2 (Visit 2) (Phase A)
|
Physiolis Autoinjector at 2° to 8°C
n=18 participants at risk
Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
|
Current Autoinjector 2° to 8°C
n=27 participants at risk
Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
|
Physiolis Autoinjector 20° to 27°C
n=16 participants at risk
Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
|
Current Autoinjector 20° to 27°C
n=20 participants at risk
Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
2.4%
1/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
General disorders
Injection site reaction
|
0.00%
0/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
2.4%
1/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
General disorders
Odema
|
2.5%
1/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
General disorders
Odema peripheral
|
2.5%
1/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
General disorders
Swelling
|
2.5%
1/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
Infections and infestations
Sinusitis
|
2.5%
1/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
2.4%
1/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
2.4%
1/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
2.4%
1/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
2.4%
1/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
2.4%
1/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
2.4%
1/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
2.4%
1/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
3.7%
1/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/40 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/42 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/41 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/18 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
3.7%
1/27 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/16 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
0.00%
0/20 • Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent.
Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up.
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER