Trial Outcomes & Findings for Surveillance of Humira Injection in Korean Patients (NCT NCT01083121)
NCT ID: NCT01083121
Last Updated: 2013-08-21
Results Overview
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.
Recruitment status
COMPLETED
Target enrollment
1779 participants
Primary outcome timeframe
From Baseline until up to 70 days after the 3 month study period (total of 160 days).
Results posted on
2013-08-21
Participant Flow
Participant milestones
| Measure |
Adalimumab
Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
|
|---|---|
|
Overall Study
STARTED
|
1779
|
|
Overall Study
COMPLETED
|
1698
|
|
Overall Study
NOT COMPLETED
|
81
|
Reasons for withdrawal
| Measure |
Adalimumab
Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
|
|---|---|
|
Overall Study
Use of Humira outside the approved label
|
81
|
Baseline Characteristics
Surveillance of Humira Injection in Korean Patients
Baseline characteristics by cohort
| Measure |
Adalimumab
n=1698 Participants
Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
|
|---|---|
|
Age Continuous
|
41.80 years
STANDARD_DEVIATION 13.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
729 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
969 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
1,698 participants
n=5 Participants
|
|
Indication
Rheumatoid arthritis
|
652 participants
n=5 Participants
|
|
Indication
Psoriatic arthritis
|
47 participants
n=5 Participants
|
|
Indication
Ankylosing spondylitis
|
925 participants
n=5 Participants
|
|
Indication
Crohn's disease
|
73 participants
n=5 Participants
|
|
Indication
Psoriasis
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline until up to 70 days after the 3 month study period (total of 160 days).Population: Safety analysis population
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.
Outcome measures
| Measure |
Adalimumab
n=1698 Participants
Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
|
Psoriatic Arthritis
Participants with active and progressive psoriatic arthritis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
|
Ankylosing Spondylitis
Participants with severe active ankylosing spondylitis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
|
Crohn's Disease
Participants with severely active Crohn's disease who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any adverse event
|
171 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Any adverse drug reaction
|
116 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse events
|
47 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Mild adverse event
|
115 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Moderate adverse event
|
58 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Severe adverse event
|
7 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Discontinued adalimumab due to adverse event
|
30 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Adverse events related to adalimumab
|
120 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Unexpected adverse drug reaction
|
21 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After 3-month treatmentPopulation: Effectiveness evaluation was performed in 1,471 participants who received adalimumab for at least 3 months and in whom investigator's assessment at 3 months was available. No participants were available in the Psoriasis group for effectiveness evaluation.
The investigator's overall assessment for effectiveness was recorded as 'Improved', 'No change', 'Aggravated,' or 'Not assessable'.
Outcome measures
| Measure |
Adalimumab
n=541 Participants
Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
|
Psoriatic Arthritis
n=40 Participants
Participants with active and progressive psoriatic arthritis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
|
Ankylosing Spondylitis
n=834 Participants
Participants with severe active ankylosing spondylitis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
|
Crohn's Disease
n=56 Participants
Participants with severely active Crohn's disease who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
|
|---|---|---|---|---|
|
Physician's Global Assessment for Effectiveness
Aggravated
|
11 participants
|
1 participants
|
3 participants
|
0 participants
|
|
Physician's Global Assessment for Effectiveness
Improved
|
478 participants
|
37 participants
|
790 participants
|
50 participants
|
|
Physician's Global Assessment for Effectiveness
No change
|
52 participants
|
2 participants
|
41 participants
|
6 participants
|
|
Physician's Global Assessment for Effectiveness
Not assessable
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Adalimumab
Serious events: 47 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab
n=1698 participants at risk
Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
|
|---|---|
|
Infections and infestations
Pyelonephritis
|
0.24%
4/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Infections and infestations
Pneumonia
|
0.12%
2/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.12%
2/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Infections and infestations
Herpes zoster
|
0.12%
2/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Infections and infestations
Peritoneal tuberculosis
|
0.12%
2/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Infections and infestations
Tuberculosis
|
0.12%
2/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Infections and infestations
Renal tuberculosis
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Infections and infestations
Bursitis infective
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Infections and infestations
Malaria
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Infections and infestations
Anal abscess
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Infections and infestations
Peritoneal abscess
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
3/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.12%
2/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Gastrointestinal disorders
Vomiting
|
0.12%
2/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Gastrointestinal disorders
Colitis
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Gastrointestinal disorders
Peritonitis
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Gastrointestinal disorders
Nausea
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.12%
2/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Nervous system disorders
Paralysis
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Nervous system disorders
Dementia
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
General disorders
Asthenia
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
General disorders
Pyrexia
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
General disorders
Pain
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Surgical and medical procedures
Knee operation
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Surgical and medical procedures
Small intestinal resection
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Investigations
Blood creatinine increased
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Investigations
Haemoglobin decreased
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Immune system disorders
Allergy to sting
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Cardiac disorders
Myocardial infarction
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.06%
1/1698 • For up to 70 days after the 3 month study period (total of 160 days).
|
Other adverse events
Adverse event data not reported
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