Trial Outcomes & Findings for A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab (NCT NCT01502423)

NCT ID: NCT01502423

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: 61 participants
• Primary outcome timeframe: Immediately after injection.
• Results posted on: 2014-02-20

Participant Flow

One participant, who was randomized to the New formulation of adalimumab/Current formulation adalimumab arm, 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	31	30
Overall Study COMPLETED	31	29
Overall Study NOT COMPLETED	0	1

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	0	1

Baseline Characteristics

A Crossover Study of the 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=29 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=60 Participants Total of all reporting groups
Age, Continuous	58.3 years STANDARD_DEVIATION 11.56 • n=5 Participants	54.4 years STANDARD_DEVIATION 14.11 • n=7 Participants	56.4 years STANDARD_DEVIATION 12.90 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 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=60 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=60 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)	4.2 cm Standard Deviation 2.72	0.9 cm Standard Deviation 1.44

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.

Outcome measures

Measure	Current Formulation Adalimumab n=60 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=60 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 1.61	0.4 cm Standard Deviation 1.08

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=60 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=60 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	80 Percentage of Participants	90 Percentage of Participants
Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale 30 minutes	81.7 Percentage of Participants	91.7 Percentage of Participants

SECONDARY outcome

Timeframe: 10 minutes and 30 minutes after injection

Erythema (redness) was assessed.

Outcome measures

Measure	Current Formulation Adalimumab n=60 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=60 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	50 Percentage of Participants	63.3 Percentage of Participants
Percentage of Participants With no Erythema in the Draize Scale 30 minutes	60 Percentage of Participants	75 Percentage of Participants

SECONDARY outcome

Timeframe: 10 minutes and 30 minutes after injection

Edema (swelling) was assessed.

Outcome measures

Measure	Current Formulation Adalimumab n=60 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=60 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	90 Percentage of Participants	93.3 Percentage of Participants
Percentage of Participants With no Edema in the Draize Scale 30 minutes	91.7 Percentage of Participants	95 Percentage of Participants

SECONDARY outcome

Timeframe: 10 minutes and 30 minutes after injection

Pruritus (itching) was assessed.

Outcome measures

Measure	Current Formulation Adalimumab n=60 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=60 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 10 minutes	98.3 Percentage of Participants	95 Percentage of Participants
Percentage of Participants With no Pruritus in the Draize Scale 30 minutes	96.7 Percentage of Participants	96.7 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 that 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=60 Participants One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=60 Participants One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
Number of Participants With Adverse Events (AEs)	8 participants	4 participants

Adverse Events

Current Formulation Adalimumab

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

New Formulation of Adalimumab

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Current Formulation Adalimumab n=60 participants at risk One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe	New Formulation of Adalimumab n=60 participants at risk One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
General disorders CYST	1.7% 1/60 • 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% 0/60 • 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.
General disorders INJECTION SITE PRURITUS	0.00% 0/60 • 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.	1.7% 1/60 • 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.
General disorders INJECTION SITE REACTION	0.00% 0/60 • 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.	1.7% 1/60 • 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.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	1.7% 1/60 • 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% 0/60 • 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.
Infections and infestations RESPIRATORY TRACT INFECTION VIRAL	1.7% 1/60 • 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% 0/60 • 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.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	3.3% 2/60 • 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.	1.7% 1/60 • 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.
Infections and infestations URINARY TRACT INFECTION	3.3% 2/60 • 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% 0/60 • 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.
Injury, poisoning and procedural complications CONTUSION	1.7% 1/60 • 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% 0/60 • 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.
Injury, poisoning and procedural complications POST-TRAUMATIC PAIN	0.00% 0/60 • 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.	1.7% 1/60 • 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.
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	1.7% 1/60 • 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% 0/60 • 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.
Nervous system disorders HEADACHE	1.7% 1/60 • 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% 0/60 • 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.
Psychiatric disorders DEPRESSION	1.7% 1/60 • 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% 0/60 • 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.
Respiratory, thoracic and mediastinal disorders ASTHMA	1.7% 1/60 • 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% 0/60 • 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.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	1.7% 1/60 • 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% 0/60 • 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