Trial Outcomes & Findings for Crossover Study of Safety and Tolerability of Two Formulations of Adalimumab. (NCT NCT01561313)

NCT ID: NCT01561313

Last Updated: 2014-02-20

Results Overview

The primary response variable is participant's immediate pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm), with 0 representing no pain and 10 representing the worst possible pain.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 64 participants
• Primary outcome timeframe: Immediately after injection
• Results posted on: 2014-02-20

Participant Flow

Two participants, who were randomized to the Current formulation adalimumab/New formulation of adalimumab arm of the study, were excluded from the analysis of injection site-related pain. One participant received one dose of study drug and discontinued because of an adverse event, while the other discontinued before receiving any study drug.

Participant milestones

Measure	Current Formulation Adalimumab/New Formulation of Adalimumab First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.	New Formulation of Adalimumab/Current Formulation Adalimumab First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
Overall Study STARTED	33	31
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Current Formulation Adalimumab/New Formulation of Adalimumab First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.	New Formulation of Adalimumab/Current Formulation Adalimumab First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
Overall Study Withdrawal by Subject	1	0
Overall Study Adverse event and withdrawal by subject	1	0

Baseline Characteristics

Crossover Study of Safety and Tolerability of Two Formulations of Adalimumab.

Baseline characteristics by cohort

Measure	Current Formulation Adalimumab/New Formulation of Adalimumab n=31 Participants First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.	New Formulation of Adalimumab/Current Formulation Adalimumab n=31 Participants First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.	Total n=62 Participants Total of all reporting groups
Age, Continuous	51.1 years STANDARD_DEVIATION 12.57 • n=5 Participants	58.6 years STANDARD_DEVIATION 13.53 • n=7 Participants	54.8 years STANDARD_DEVIATION 13.49 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after injection

The primary response variable is participant's immediate pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm), with 0 representing no pain and 10 representing the worst possible pain.

Outcome measures

Measure	Current Formulation Adalimumab n=62 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=62 Participants One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
Mean Injection Site Pain on a Visual Analogue Scale (VAS)	3.3 cm Standard Deviation 2.11	1.6 cm Standard Deviation 2.09

SECONDARY outcome

Timeframe: 15 minutes post injection

The secondary response variable is participant's pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm) recorded 15 minutes after the injection, with 0 representing no pain and 10 representing the worst possible pain.

Outcome measures

Measure	Current Formulation Adalimumab n=62 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=62 Participants One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
Mean Injection Site Pain on a Visual Analogue Scale (VAS)	1.0 cm Standard Deviation 1.52	0.9 cm Standard Deviation 1.66

SECONDARY outcome

Timeframe: 10 minutes and 30 minutes after injection

Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.

Outcome measures

Measure	Current Formulation Adalimumab n=62 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=62 Participants One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale 10 minutes	91.9 Percentage of Participants	96.8 Percentage of Participants
Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale 30 minutes	98.4 Percentage of Participants	98.4 Percentage of Participants

SECONDARY outcome

Timeframe: 10 minutes and 30 minutes after injection

Erythema (redness) was assessed.

Outcome measures

Measure	Current Formulation Adalimumab n=62 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=62 Participants One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
Percentage of Participants With no Erythema in the Draize Scale 10 minutes	69.4 Percentage of Participants	64.5 Percentage of Participants
Percentage of Participants With no Erythema in the Draize Scale 30 minutes	75.8 Percentage of Participants	72.6 Percentage of Participants

SECONDARY outcome

Timeframe: 10 minutes and 30 minutes after injection

Edema (swelling) was assessed.

Outcome measures

Measure	Current Formulation Adalimumab n=62 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=62 Participants One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
Percentage of Participants With no Edema in the Draize Scale 10 minutes	80.6 Percentage of Participants	83.9 Percentage of Participants
Percentage of Participants With no Edema in the Draize Scale 30 minutes	85.5 Percentage of Participants	85.5 Percentage of Participants

SECONDARY outcome

Timeframe: 10 minutes and 30 minutes after injection

Pruritus (itching) was assessed.

Outcome measures

Measure	Current Formulation Adalimumab n=62 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=62 Participants One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
Percentage of Participants With no Pruritus in the Draize Scale 30 minutes	98.4 Percentage of Participants	98.4 Percentage of Participants
Percentage of Participants With no Pruritus in the Draize Scale 10 minutes	100 Percentage of Participants	98.4 Percentage of Participants

SECONDARY outcome

Timeframe: Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. Serious Adverse Events were collected from the time the participant signed the informed consent.

An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.

Outcome measures

Measure	Current Formulation Adalimumab n=63 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=62 Participants One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
Number of Participants With Adverse Events (AEs)	2 participants	1 participants

Adverse Events

Current Formulation Adalimumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

New Formulation of Adalimumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Current Formulation Adalimumab n=63 participants at risk One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=62 participants at risk One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
Infections and infestations PHARYNGITIS	1.6% 1/63 • Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the study-specific informed consent.	0.00% 0/62 • Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the study-specific informed consent.
Investigations PROTEIN URINE PRESENT	0.00% 0/63 • Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the study-specific informed consent.	1.6% 1/62 • Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the study-specific informed consent.
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	1.6% 1/63 • Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the study-specific informed consent.	0.00% 0/62 • Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the study-specific informed consent.

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