ClinicalTrials.gov
ClinicalTrials.gov Menu

A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01086033
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : September 26, 2013
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Time Perspective: Prospective
Condition Rheumatoid Arthritis
Enrollment 566
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Humira
Hide Arm/Group Description Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Period Title: Overall Study
Started 566
Completed 262
Not Completed 304
Reason Not Completed
Lack of efficacy/Exacerbation of RA             86
Lost to Follow-up             86
Adverse Event             42
Withdrawal by Subject             41
Other             14
Other             13
AE and Withdrew Consent             5
Withdrew Consent and Lack of Efficacy             5
Withdrew consent and Other Reason             4
AE and Lack of Efficacy             4
Death             1
AE and Lost to Follow-up             1
AE and Other Reason             1
AE, Withdrew Consent & Lack of Efficacy             1
Arm/Group Title Humira
Hide Arm/Group Description Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Overall Number of Baseline Participants 566
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 566 participants
56.8  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 566 participants
Female
456
  80.6%
Male
110
  19.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Greece Number Analyzed 566 participants
566
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant.

Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population, including all patients that received at least one dose of the study drug.
Arm/Group Title Humira
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Overall Number of Participants Analyzed 566
Measure Type: Number
Unit of Measure: participants
Any Adverse Event 262
Serious Adverse Event 65
2.Primary Outcome
Title Disease Activity Score (DAS) 28 Over Time
Hide Description The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Time Frame Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population; "n" indicates the number of participants with available data at each time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Overall Number of Participants Analyzed 566
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=555) 6.0  (1.2)
Month 3 (n=510) 4.2  (1.4)
Month 6 (n=449) 3.8  (1.5)
Month 9 (n=401) 3.5  (1.5)
Month 12 (n=379) 3.5  (1.5)
Month 18 (n=333) 3.3  (1.5)
Month 24 (n=298) 3.2  (1.5)
Month 30 (n=264) 3.0  (1.4)
Month 36 (n=254) 2.9  (1.4)
3.Primary Outcome
Title European League Against Rheumatism (EULAR) Response
Hide Description

A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.

A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of > 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.

A Moderate EULAR Response is defined as either:

  • an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1, or
  • an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.

No Response is defined as either:

  • an improvement (decrease) in the DAS28 of ≤ to 0.6, or
  • an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1.
Time Frame Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population;
Arm/Group Title Good Response Moderate Response No Response
Hide Arm/Group Description:
Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Good Response per EULAR criteria.
Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.
Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
Overall Number of Participants Analyzed 566 566 566
Measure Type: Number
Unit of Measure: participants
Month 3 (n=501) 112 242 147
Month 6 (n=443) 154 193 96
Month 9 (n=394) 173 147 74
Month 12 (n=373) 171 139 63
Month 18 (n=327) 168 105 54
Month 24 (n=294) 169 84 41
Month 30 (n=262) 155 78 29
Month 36 (n=253) 156 68 29
4.Primary Outcome
Title Number of Participants With an American College of Rheumatology (ACR) 20 Response
Hide Description

American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

  • ≥ 20% improvement in tender joint count;
  • ≥ 20% improvement in swollen joint count; and
  • ≥ 20% improvement in at least 3 of the 5 following parameters:

    • Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
    • Patient's global assessment of disease activity (measured on a 100 mm VAS);
    • Physician's global assessment of disease activity (measured on a 100 mm VAS);
    • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
    • Acute phase reactant value (C-reactive protein [CRP]).
Time Frame Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. "n" indicates the number of patients for whom ACR20 could be calculated at each time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Overall Number of Participants Analyzed 566
Measure Type: Number
Unit of Measure: participants
Month 3 (n=491) 265
Month 6 (n=427) 279
Month 9 (n=384) 263
Month 12 (n=363) 248
Month 18 (n=330) 241
Month 24 (n=293) 216
Month 30 (n=259) 198
Month 36 (n=248) 194
5.Primary Outcome
Title Number of Participants With an American College of Rheumatology (ACR) 50 Response
Hide Description

American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

  • ≥ 50% improvement in tender joint count;
  • ≥ 50% improvement in swollen joint count; and
  • ≥ 50% improvement in at least 3 of the 5 following parameters:

    • Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
    • Patient's global assessment of disease activity (measured on a 100 mm VAS);
    • Physician's global assessment of disease activity (measured on a 100 mm VAS);
    • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
    • Acute phase reactant value (C-reactive protein [CRP]).
Time Frame Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. "n" indicates the number of patients for whom ACR50 could be calculated at each time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Overall Number of Participants Analyzed 566
Measure Type: Number
Unit of Measure: participants
Month 3 (n=498) 134
Month 6 (n=433) 188
Month 9 (n=388) 205
Month 12 (n=368) 182
Month 18 (n=333) 184
Month 24 (n=291) 170
Month 30 (n=256) 161
Month 36 (n=250) 164
6.Primary Outcome
Title Number of Participants With an American College of Rheumatology (ACR) 70 Response
Hide Description

American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

  • ≥ 70% improvement in tender joint count;
  • ≥ 70% improvement in swollen joint count; and
  • ≥ 70% improvement in at least 3 of the 5 following parameters:

    • Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
    • Patient's global assessment of disease activity (measured on a 100 mm VAS);
    • Physician's global assessment of disease activity (measured on a 100 mm VAS);
    • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
    • Acute phase reactant value (C-reactive protein [CRP]).
Time Frame Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. "n" indicates the number of patients for whom ACR70 could be calculated at each time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Overall Number of Participants Analyzed 566
Measure Type: Number
Unit of Measure: participants
Month 3 (n=495) 67
Month 6 (n=435) 118
Month 9 (n=390) 147
Month 12 (n=373) 142
Month 18 (n=330) 154
Month 24 (n=294) 149
Month 30 (n=261) 139
Month 36 (n=253) 144
7.Secondary Outcome
Title Percentage of Participants Who Missed at Least One Dose of Humira
Hide Description Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.
Time Frame Months 3, 6, 9, 12, 18, 24, 30, and 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population; "n" indicates the number of participants with available data at each time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Overall Number of Participants Analyzed 566
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 (n=512) 6.6
Month 6 (n=451) 8.6
Month 9 (n=406) 7.4
Month 12 (n=384) 7.3
Month 18 (n=341) 8.2
Month 24 (n=303) 7.6
Month 30 (n=271) 5.5
Month 36 (n=262) 4.2
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Humira
Hide Arm/Group Description Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
All-Cause Mortality
Humira
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Humira
Affected / at Risk (%)
Total   65/566 (11.48%) 
Blood and lymphatic system disorders   
Anemia  2/566 (0.35%) 
Lymph nodes enlarged  1/566 (0.18%) 
Pancytopenia  1/566 (0.18%) 
Thrombocytopenia  1/566 (0.18%) 
Thrombotic thrombocytopenic purpura  1/566 (0.18%) 
Cardiac disorders   
Acute myocardial infarction/Myocardial infarction  2/566 (0.35%) 
Atrioventricular block complete  1/566 (0.18%) 
Cardiac failure aggravated  1/566 (0.18%) 
Paroxysmal upraventricular tachycardia  1/566 (0.18%) 
Pericarditis  1/566 (0.18%) 
Tachycardia  1/566 (0.18%) 
Gastrointestinal disorders   
Abdominal pain  3/566 (0.53%) 
Diarrhea  2/566 (0.35%) 
Abdominal bloating  1/566 (0.18%) 
Ascites  1/566 (0.18%) 
Colitis ulcerative aggravated  1/566 (0.18%) 
Dysphagia  1/566 (0.18%) 
Epigastric pain  1/566 (0.18%) 
Fistula  1/566 (0.18%) 
Gastrointestinal bleeding  1/566 (0.18%) 
Hypochondrium pain right  1/566 (0.18%) 
Hypogastric pain  1/566 (0.18%) 
Melaena  1/566 (0.18%) 
Nausea  1/566 (0.18%) 
Pancreatic disorder  1/566 (0.18%) 
Paresthesia circumoral  1/566 (0.18%) 
Vomiting  1/566 (0.18%) 
General disorders   
Fever/Pyrexia  7/566 (1.24%) 
Weakness/Asthenia  4/566 (0.71%) 
Fatigue  2/566 (0.35%) 
Difficulty in walking  1/566 (0.18%) 
Drug ineffective  1/566 (0.18%) 
Edema abdomen  1/566 (0.18%) 
Edema of legs  1/566 (0.18%) 
Nodule on finger  1/566 (0.18%) 
Pain  1/566 (0.18%) 
Reaction unevaluable  1/566 (0.18%) 
Swelling  1/566 (0.18%) 
Hepatobiliary disorders   
Cholangitis  1/566 (0.18%) 
Cholecystitis  1/566 (0.18%) 
Gallbladder perforation  1/566 (0.18%) 
Immune system disorders   
Anaphylaxis  1/566 (0.18%) 
Infections and infestations   
Respiratory tract infection  3/566 (0.53%) 
Viral infection  2/566 (0.35%) 
Abscesses of skin  1/566 (0.18%) 
Cellulitis  1/566 (0.18%) 
Cystitis  1/566 (0.18%) 
Escherichia urinary tract infection  1/566 (0.18%) 
Herpes zoster  1/566 (0.18%) 
Osteomyelitis  1/566 (0.18%) 
Periapical dental abscess  1/566 (0.18%) 
Perirectal abscess  1/566 (0.18%) 
Peritonitis  1/566 (0.18%) 
Peritonsillar abscess  1/566 (0.18%) 
Phlegmon  1/566 (0.18%) 
Pneumonia  1/566 (0.18%) 
Post operative infection  1/566 (0.18%) 
Postoperative wound infection  1/566 (0.18%) 
Pyelonephritis  1/566 (0.18%) 
Relapsing fever  1/566 (0.18%) 
Septic arthritis  1/566 (0.18%) 
Tuberculous peritonitis  1/566 (0.18%) 
Urinary tract infection  1/566 (0.18%) 
Viral hepatitis B  1/566 (0.18%) 
Lower respiratory tract infection  1/566 (0.18%) 
Injury, poisoning and procedural complications   
Fall  5/566 (0.88%) 
Automobile Accident  1/566 (0.18%) 
Bimalleolar fracture  1/566 (0.18%) 
Elbow fracture  1/566 (0.18%) 
Femoral neck fracture  1/566 (0.18%) 
Femur fracture  1/566 (0.18%) 
Hip fracture  1/566 (0.18%) 
Postoperative hernia  1/566 (0.18%) 
Shoulder fracture  1/566 (0.18%) 
Investigations   
Weight Loss/Weight decreased  2/566 (0.35%) 
Creatine increased  1/566 (0.18%) 
Erythrocyte sedimentation rate increased  1/566 (0.18%) 
Hematocrit decreased  1/566 (0.18%) 
Transaminases increased/Hepatic enzyme increased  1/566 (0.18%) 
Metabolism and nutrition disorders   
Hypoglycemia  1/566 (0.18%) 
Musculoskeletal and connective tissue disorders   
RA flare up  4/566 (0.71%) 
Pain in hip  2/566 (0.35%) 
Arthralgia  1/566 (0.18%) 
Arthritis  1/566 (0.18%) 
Arthritis single joint  1/566 (0.18%) 
Back pain  1/566 (0.18%) 
Hydrarthrosis  1/566 (0.18%) 
Intervertebral disc herniation  1/566 (0.18%) 
Lumbar disc herniation  1/566 (0.18%) 
Lupus-like syndrome  1/566 (0.18%) 
Muscle weakness  1/566 (0.18%) 
Periarticular disorder  1/566 (0.18%) 
Polyarthritis  1/566 (0.18%) 
Synovial cyst  1/566 (0.18%) 
Wrist deformity  1/566 (0.18%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute myelomonocytic leukemia  1/566 (0.18%) 
Collecting duct renal cancer  1/566 (0.18%) 
Lung Cancer  1/566 (0.18%) 
Lung nodule  1/566 (0.18%) 
Non-small cell lung cancer  1/566 (0.18%) 
Ovarian cancer  1/566 (0.18%) 
Ovarian germ cell cancer stage III  1/566 (0.18%) 
Parathyroid adenoma  1/566 (0.18%) 
Nervous system disorders   
Hemorrhagic stroke  2/566 (0.35%) 
Loss of consciousness  2/566 (0.35%) 
Demyelinating disease (excl. multiple sclerosis)  1/566 (0.18%) 
Movements reduced  1/566 (0.18%) 
Pregnancy, puerperium and perinatal conditions   
Pregnancy  1/566 (0.18%) 
Psychiatric disorders   
Depression  1/566 (0.18%) 
Renal and urinary disorders   
Nephrotic syndrome  1/566 (0.18%) 
Renal colic  1/566 (0.18%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  2/566 (0.35%) 
Pulmonary fibrosis  2/566 (0.35%) 
Productive cough  1/566 (0.18%) 
Throat pain  1/566 (0.18%) 
Skin and subcutaneous tissue disorders   
Hair loss  1/566 (0.18%) 
Maculopapular rash  1/566 (0.18%) 
Surgical and medical procedures   
Cholecystectomy  1/566 (0.18%) 
Fusion lumbar spine  1/566 (0.18%) 
Knee arthroplasty  1/566 (0.18%) 
Removal of surgical hardware  1/566 (0.18%) 
Vascular disorders   
Abdominal aortic aneurysm  1/566 (0.18%) 
Hypertensive crisis  1/566 (0.18%) 
Venous thrombosis limb  1/566 (0.18%) 
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Humira
Affected / at Risk (%)
Total   109/566 (19.26%) 
General disorders   
Drug ineffective  91/566 (16.08%) 
Infections and infestations   
Respiratory infection  35/566 (6.18%) 
1
Term from vocabulary, MedDRA 15.0
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.
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.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01086033     History of Changes
Other Study ID Numbers: PMOS GREC 2004 06
First Submitted: February 26, 2010
First Posted: March 12, 2010
Results First Submitted: July 17, 2013
Results First Posted: September 26, 2013
Last Update Posted: September 26, 2013