A Study of Adalimumab When Added to Inadequate Standard Anti-rheumatic Therapy in Patients With Active Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT01231321|
Recruitment Status : Completed
First Posted : November 1, 2010
Results First Posted : March 24, 2011
Last Update Posted : April 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: adalimumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Prospective, Multi-Centre Study to Assess the Safety and Efficacy of Adalimumab (Humira®) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
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.
- Frequency of Adverse Events [ Time Frame: Up to 34 weeks (24 week study treatment plus 70-day follow-up period) ]
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.
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.
- Changes of Physical Examination [ Time Frame: Baseline and 24 weeks ]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.
- Deviation From Normal Laboratory Ranges [ Time Frame: 24 weeks ]
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
- Vital Sign Values [ Time Frame: 24 weeks ]
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.
- Change in Disease Activity Score (DAS28) Compared With Baseline [ Time Frame: Baseline and 24 weeks ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231321
|Site Ref # / Investigator 17682|
|Kazan, Russian Federation, 420095|
|Site Ref # / Investigator 7417|
|Moscow, Russian Federation, 115522|
|Site Ref # / Investigator 17681|
|Moscow, Russian Federation, 117513|
|Site Ref # / Investigator 7401|
|Moscow, Russian Federation, 119049|
|Site Ref # / Investigator 18081|
|Saint Petersburg, Russian Federation, 191015|
|Study Director:||Konstantin Gudkov, MD||Abbott|