A Study of Adalimumab When Added to Inadequate Standard Anti-rheumatic Therapy in Patients With Active Rheumatoid Arthritis

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT01231321

First received: October 28, 2010

Last updated: April 20, 2011

Last verified: April 2011

History of Changes

Results First Received: February 25, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Intervention:	Drug: adalimumab

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL	Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.

Participant Flow: Overall Study

	Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL
STARTED	100
COMPLETED	95
NOT COMPLETED	5
Adverse Event	3
Lack of Efficacy	2

Baseline Characteristics

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Reporting Groups

	Description
Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL	Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.

Baseline Measures

	Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL
Number of Participants [units: participants]	100
Age [units: participants]
<=18 years	0
Between 18 and 65 years	90
>=65 years	10
Age [units: years] Mean ± Standard Deviation	50.9 ± 11.1
Gender [units: participants]
Female	89
Male	11
Region of Enrollment [units: participants]
Russian Federation	100

Outcome Measures

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1. Primary:

Frequency of Adverse Events [ Time Frame: Up to 34 weeks (24 week study treatment plus 70-day follow-up period) ]

Measure Type	Primary
Measure Title	Frequency of Adverse Events
Measure Description	Serious adverse events were collected from the time of informed consent, and nonserious adverse events were collected from the time of first dose of adalimumab, until 70 days after the last injection of adalimumab. Refer to the Reported Adverse Events section of this results disclosure for specific adverse events reported. Note: Severe events considerably interfered in patients' usual activities and may have been life-threatening. Serious events were life-threatening; resulted in hospitalization, congenital anomalies, or disability; or required intervention to prevent seriousness.
Time Frame	Up to 34 weeks (24 week study treatment plus 70-day follow-up period)
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled subjects were included in this intent-to-treat (ITT) analysis.

Reporting Groups

	Description
Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL	Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.

Measured Values

	Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL
Number of Participants Analyzed [units: participants]	100
Frequency of Adverse Events [units: participants]
Adverse events	38
Serious adverse events	1
Severe adverse events	1
Possibly or probably related to adalimumab	24
Adverse events leading to discontinuation	3
Fatal adverse events	0

No statistical analysis provided for Frequency of Adverse Events

2. Primary:

Changes of Physical Examination [ Time Frame: Baseline and 24 weeks ]

Measure Type	Primary
Measure Title	Changes of Physical Examination
Measure Description	Physical examination findings were compared between Baseline and Week 24, and changes were recorded (Normal at Baseline to Abnormal at Week 24; or Abnormal at Baseline to Normal at Week 24). Physical examination criteria (normal vs. abnormal) were at the clinical judgement of the examining physician. Significant changes in physical examination from Baseline were considered to be adverse events.
Time Frame	Baseline and 24 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled subjects with available data were included in this intent-to-treat (ITT) analysis.

Reporting Groups

	Description
Change From Normal to Abnormal	Subjects whose physical examination findings for the categories below were normal at Baseline and abnormal at 24 weeks
Change From Abnormal to Normal	Subjects whose physical examination findings for the categories below were abnormal at Baseline and normal at 24 weeks

Measured Values

	Change From Normal to Abnormal	Change From Abnormal to Normal
Number of Participants Analyzed [units: participants]	99	99
Changes of Physical Examination [units: participants]
General Appearance	0	0
Head	0	0
Ears	0	0
Eyes	1	0
Nose	0	0
Throat	0	0
Neck	0	0
Thyroid	0	0
Lungs/Chest	0	0
Cardiovascular	1	0
Abdomen	0	0
Musculoskeletal	0	0
Extremities	0	0
Skin	0	1
Lymph nodes	1	1
Neurological	0	0
Genitourinary	0	0
Other	0	0

No statistical analysis provided for Changes of Physical Examination

3. Primary:

Deviation From Normal Laboratory Ranges [ Time Frame: 24 weeks ]

Measure Type	Primary
Measure Title	Deviation From Normal Laboratory Ranges
Measure Description	Laboratory values were assessed for values above and below the normal (reference) ranges used by the central laboratory. Note abbreviations used in table: Alk. phosphatase = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, ESR = erythrocyte sedimentation rate
Time Frame	24 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects with available data were included in this intent-to-treat (ITT) analysis. The number of subjects with available data is indicated for each laboratory assessment.

Reporting Groups

	Description
Below Reference Range	Subjects with laboratory values at Week 24 lower than the reference range indicated for each parameter
Above Reference Range	Subjects with laboratory values at Week 24 higher than the reference range indicated for each parameter

Measured Values

	Below Reference Range	Above Reference Range
Number of Participants Analyzed [units: participants]	100	100
Deviation From Normal Laboratory Ranges [units: participants]
Basophils (%) (ref. range: 0% - 1%) (n = 95)	0	0
Basophils (ref. range 0 - 2 x 10^9/L) (n = 94)	0	0
Eosinophils (%) (ref. range 1% - 5%) (n = 95)	17	11
Eosinophils (ref. range 0 - 1 x 10^9/L) (n = 94)	0	0
Erythrocytes (ref. range 4 - 5 x 10^12/L) (n = 95)	15	9
ESR (ref. range 0 - 30 mm/h) (n = 75)	0	14
Hematocrit (ref. range 35% - 47%) (n = 95)	15	2
Hemoglobin (ref. range 12 - 16 g/dL) (n = 95)	33	1
Leucocytes (ref. range 4 - 11 x 10^3/L) (n = 95)	3	10
Lymphocytes (%) (ref. range 19% - 37%) (n = 95)	15	24
Lymphocytes (ref. range 2 - 4 x 10^9/L) (n = 94)	44	6
Monocytes (%) (ref. range 3% - 11%) (n = 95)	1	12
Monocytes (ref. range 0 - 1 x 10^9/L) (n = 94)	0	6
Neutrophils (%) (ref. range 48% - 78%) (n = 95)	20	6
Neutrophils (ref. range 2 - 9 x 10^9/L) (n = 95)	5	3
Platelets (ref. range 150-400 x 10^3/mcL) (n = 95)	0	9
Albumin (ref. range 35 - 50 g/L) (n = 97)	0	14
Alk. phosphatase (ref. range 40-150 U/L) (n = 97)	1	2
ALT (ref. range 0 - 31 U/L) (n = 97)	0	9
AST (ref. range 0 - 31 U/L) (n = 97)	0	6
Calcium (ref. range 2 - 3 mmol/L) (n = 97)	1	0
Chloride (ref. range 98 - 107 mEq/L) (n = 96)	0	0
Creatine kinase (ref. range 0 - 167 U/L) (n = 97)	0	2
Creatinine (ref. range 53 - 97 mcmol/L) (n = 97)	1	1
C-reactive protein (ref. range 0-5 mg/L) (n = 97)	0	45
Glucose (ref. range 4- 6 mmol/L) (n = 97)	4	10
Potassium (ref. range 4 - 6 mmol/L) (n = 97)	21	0
Sodium (ref. range 136 - 145 mmol/L) (n = 97)	2	0
Total bilirubin (ref. range 3-20 mcmol/L) (n = 97)	0	5
Total cholesterol (ref. range 4-8 mmol/L) (n = 97)	5	4
Total protein (ref. range 64-83 g/L) (n = 97)	3	2
Urea (ref. range 2 - 6 mmol/L) (n = 96)	0	30
Urea nitrogen (ref. range 6 - 20 mg/dL) (n = 97)	0	11
Uric acid (ref. range 150 - 350 mcmol/L) (n = 97)	11	6
Urine pH (ref. range 5 - 8) (n = 98)	0	1

No statistical analysis provided for Deviation From Normal Laboratory Ranges

4. Primary:

Vital Sign Values [ Time Frame: 24 weeks ]

Measure Type	Primary
Measure Title	Vital Sign Values
Measure Description	Vital signs values were assessed for values above and below the normal (reference) ranges used by the central laboratory. Note, in table, BP = blood pressure.
Time Frame	24 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects with available data were included in this intent-to-treat (ITT) analysis.

Reporting Groups

	Description
Below Reference Range	Subjects with vital sign values at Week 24 lower than the reference range indicated for each parameter
Above Reference Range	Subjects with vital sign values at Week 24 higher than the reference range indicated for each parameter

Measured Values

	Below Reference Range	Above Reference Range
Number of Participants Analyzed [units: participants]	99	99
Vital Sign Values [units: participants]
Systolic BP (ref. range 100 - 140 mm Hg)	1	2
Diastolic BP (ref. range 60 - 100 mm Hg)	0	0
Pulse (ref. range 50 - 90 beats/min)	0	0
Body temperature (ref. range 36 - 37 degrees C)	1	0

No statistical analysis provided for Vital Sign Values

5. Secondary:

Change in Disease Activity Score (DAS28) Compared With Baseline [ Time Frame: Baseline and 24 weeks ]

Measure Type	Secondary
Measure Title	Change in Disease Activity Score (DAS28) Compared With Baseline
Measure Description	The DAS28 is validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health (patient's global assessment of disease activity) were included in the DAS28 score. Scores on the DAS28 range from 1 (inactive disease) to 10 (very active disease).
Time Frame	Baseline and 24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects with data available from both Baseline and Week 24 were included in this intent-to-treat (ITT) analysis.

Reporting Groups

	Description
Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL	Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.

Measured Values

	Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL
Number of Participants Analyzed [units: participants]	96
Change in Disease Activity Score (DAS28) Compared With Baseline [units: units on a scale] Mean ± Standard Deviation	-2.74 ± 1.18

No statistical analysis provided for Change in Disease Activity Score (DAS28) Compared With Baseline

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110

No publications provided

Responsible Party:	Konstantin Gudkov/ Clinical Research Manager, Abbott Laboratories LLC Russia
ClinicalTrials.gov Identifier:	NCT01231321 History of Changes
Other Study ID Numbers:	W06-406
Study First Received:	October 28, 2010
Results First Received:	February 25, 2011
Last Updated:	April 20, 2011
Health Authority:	Russia: Ministry of Health of the Russian Federation Russia: Ethics Committee

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