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Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859 (NCT00870467))

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ClinicalTrials.gov Identifier: NCT01163292
Recruitment Status : Completed
First Posted : July 15, 2010
Results First Posted : December 11, 2013
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Enrollment 220
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adalimumab Non-Adalimumab
Hide Arm/Group Description Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859) Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
Period Title: Overall Study
Started 106 114
Completed 65 92
Not Completed 41 22
Reason Not Completed
Lack of Efficacy             9             0
Adverse Event             6             0
Initiation of biological therapy             0             15
Sufficient response to adalimumab             8             0
Refusal to receive adalimumab             7             0
Economic reasons             6             0
No further visits             5             7
Arm/Group Title Adalimumab Non-Adalimumab Total
Hide Arm/Group Description Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859) Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859) Total of all reporting groups
Overall Number of Baseline Participants 106 114 220
Hide Baseline Analysis Population Description
All participants registered
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 114 participants 220 participants
56.0  (13.0) 54.7  (12.3) 55.3  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 114 participants 220 participants
Female
87
  82.1%
92
  80.7%
179
  81.4%
Male
19
  17.9%
22
  19.3%
41
  18.6%
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 106 participants 114 participants 220 participants
55.46  (8.99) 57.53  (11.08) 56.53  (10.16)
Rheumatoid arthritis duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 114 participants 220 participants
1.290  (0.428) 1.316  (0.438) 1.303  (0.433)
Prior Disease Modifying Anti-Rheumatic Drug (except methotrexate)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants 114 participants 220 participants
Yes 58 51 109
No 48 63 111
Concomitant Glucocorticoid Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants 114 participants 220 participants
Yes 33 30 63
No 73 84 157
Rheumatoid Factor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants 114 participants 220 participants
Positive 60 71 131
Negative 46 43 89
Health Assessment Questionnaire Disability Index (HAQ-DI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 106 participants 114 participants 220 participants
0.29  (0.34) 0.25  (0.33) 0.27  (0.34)
[1]
Measure Description: Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Disease Activity Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 106 participants 114 participants 220 participants
2.89  (1.10) 2.74  (1.11) 2.81  (1.11)
[1]
Measure Description: The Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient’s global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity).
Modified Total Sharp Score (mTSS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 106 participants 114 participants 220 participants
15.61  (22.19) 16.47  (22.30) 16.05  (22.20)
[1]
Measure Description: Modified Total Sharp Score (mTSS) is a method of assessing radiographs, used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]).
Matrix Metalloprotease (MMP-3)   [1] 
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 106 participants 114 participants 220 participants
Male 149.95  (114.81) 113.70  (135.15) 130.50  (125.92)
Female 86.94  (113.09) 88.88  (182.09) 87.94  (152.09)
[1]
Measure Description: Matrix metalloprotease level in serum
1.Primary Outcome
Title Disease Activity Score (DAS28)
Hide Description The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Time Frame Weeks 0, 26, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with post-baseline DAS28 data, using last-observation-carried forward (LOCF) imputation method.
Arm/Group Title Adalimumab Non-Adalimumab
Hide Arm/Group Description:
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
Overall Number of Participants Analyzed 91 95
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 2.93  (1.05) 2.73  (1.04)
Week 26 2.72  (1.12) 3.17  (1.11)
Week 52 2.70  (1.08) 3.20  (1.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab, Non-Adalimumab
Comments Week 0
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.144
Comments [Not Specified]
Method Wilcoxon Rank Sum
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab, Non-Adalimumab
Comments Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Wilcoxon Rank Sum
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab, Non-Adalimumab
Comments Week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Wilcoxon Rank Sum
Comments [Not Specified]
2.Secondary Outcome
Title Matrix Metalloprotease-3 (MMP-3)
Hide Description MMP-3 level in serum. Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female)
Time Frame Weeks 0, 26, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with post-baseline MMP-3 data, using LOCF imputation method
Arm/Group Title Adalimumab Non-Adalimumab
Hide Arm/Group Description:
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
Overall Number of Participants Analyzed 93 96
Measure Type: Number
Unit of Measure: units on a scale
Week 0 Positive 36 30
Week 0 Negative 57 66
Week 26 Positive 34 35
Week 26 Negative 59 61
Week 52 Positive 21 43
Week 52 Negative 72 53
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab, Non-Adalimumab
Comments Week 0
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.290
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab, Non-Adalimumab
Comments Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab, Non-Adalimumab
Comments Week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52
Hide Description Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
Time Frame Week 0 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with post-baseline mTSS data, using LOCF imputation method
Arm/Group Title Adalimumab Non-Adalimumab
Hide Arm/Group Description:
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
Overall Number of Participants Analyzed 86 96
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.8  (3.9) 0.6  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab, Non-Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.335
Comments [Not Specified]
Method Wilcoxon Rank Sum
Comments [Not Specified]
4.Secondary Outcome
Title Health Assessment Questionnaire Disability Index (HAQ-DI)
Hide Description Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.
Time Frame Weeks 0, 26, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with post-baseline HAQ-DI data, using LOCF imputation method
Arm/Group Title Adalimumab Non-Adalimumab
Hide Arm/Group Description:
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
Overall Number of Participants Analyzed 85 82
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 0.27  (0.32) 0.24  (0.33)
Week 26 0.20  (0.32) 0.24  (0.36)
Week 52 0.20  (0.29) 0.26  (0.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab, Non-Adalimumab
Comments Week 0
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.266
Comments [Not Specified]
Method Wilcoxon Rank Sum
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab, Non-Adalimumab
Comments Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.440
Comments [Not Specified]
Method Wilcoxon Rank Sum
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab, Non-Adalimumab
Comments Week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.609
Comments [Not Specified]
Method Wilcoxon Rank Sum
Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.
Time Frame Week 0 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants registered
Arm/Group Title Adalimumab Non-Adalimumab
Hide Arm/Group Description:
Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
Overall Number of Participants Analyzed 106 114
Measure Type: Number
Unit of Measure: participants
51 39
Time Frame Week 0 to Week 52
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adalimumab Non-Adalimumab
Hide Arm/Group Description Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859) Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
All-Cause Mortality
Adalimumab Non-Adalimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab Non-Adalimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   5/106 (4.72%)   3/114 (2.63%) 
Gastrointestinal disorders     
Inguinal hernia * 1  0/106 (0.00%)  1/114 (0.88%) 
Infections and infestations     
Gastroenteritis * 2  1/106 (0.94%)  0/114 (0.00%) 
Herpes zoster * 2  1/106 (0.94%)  0/114 (0.00%) 
Pneumonia * 2  1/106 (0.94%)  1/114 (0.88%) 
Pyelonephritis acute * 2  1/106 (0.94%)  0/114 (0.00%) 
Sepsis * 2  1/106 (0.94%)  0/114 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Large intestine carcinoma * 2  0/106 (0.00%)  1/114 (0.88%) 
Skin and subcutaneous tissue disorders     
Scar * 2  1/106 (0.94%)  0/114 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA/J Ver. 15.1
2
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adalimumab Non-Adalimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   46/106 (43.40%)   36/114 (31.58%) 
Cardiac disorders     
Angina pectoris * 2  0/106 (0.00%)  1/114 (0.88%) 
Eye disorders     
Cataract * 1  2/106 (1.89%)  0/114 (0.00%) 
Conjunctivitis * 2  0/106 (0.00%)  1/114 (0.88%) 
Dry eye * 2  0/106 (0.00%)  1/114 (0.88%) 
Punctate keratitis * 2  0/106 (0.00%)  1/114 (0.88%) 
Xerophthalmia * 2  0/106 (0.00%)  1/114 (0.88%) 
Gastrointestinal disorders     
Constipation * 2  2/106 (1.89%)  0/114 (0.00%) 
Stomatitis * 2  5/106 (4.72%)  1/114 (0.88%) 
Abdominal pain * 2  1/106 (0.94%)  0/114 (0.00%) 
Abdominal pain upper * 2  0/106 (0.00%)  1/114 (0.88%) 
Chelitis * 2  0/106 (0.00%)  1/114 (0.88%) 
Dental caries * 2  0/106 (0.00%)  1/114 (0.88%) 
Diarrhoea * 2  1/106 (0.94%)  0/114 (0.00%) 
Dry mouth * 2  0/106 (0.00%)  1/114 (0.88%) 
Gastric ulcer * 2  1/106 (0.94%)  0/114 (0.00%) 
Toothache * 2  0/106 (0.00%)  1/114 (0.88%) 
Vomiting * 2  1/106 (0.94%)  0/114 (0.00%) 
Pancreatic enlargement * 2  1/106 (0.94%)  0/114 (0.00%) 
General disorders     
Injection site reaction * 2  4/106 (3.77%)  0/114 (0.00%) 
Pyrexia * 2  2/106 (1.89%)  0/114 (0.00%) 
Malaise * 2  1/106 (0.94%)  0/114 (0.00%) 
Hepatobiliary disorders     
Liver disorder (enzyme elevation) * 2  1/106 (0.94%)  2/114 (1.75%) 
Hepatic function abnormal * 2  0/106 (0.00%)  1/114 (0.88%) 
Hepatic steatosis * 2  1/106 (0.94%)  1/114 (0.88%) 
Driug-induced liver injury * 2  0/106 (0.00%)  1/114 (0.88%) 
Infections and infestations     
Bronchitis * 2  3/106 (2.83%)  2/114 (1.75%) 
Gastroenteritis * 2  3/106 (2.83%)  0/114 (0.00%) 
Herpes zoster * 2  2/106 (1.89%)  0/114 (0.00%) 
Nasopharyngitis * 2  13/106 (12.26%)  8/114 (7.02%) 
Pharyngitis * 2  1/106 (0.94%)  2/114 (1.75%) 
Pneumonia * 2  1/106 (0.94%)  1/114 (0.88%) 
Oral herpes * 2  2/106 (1.89%)  3/114 (2.63%) 
Acute sinusitis * 2  1/106 (0.94%)  0/114 (0.00%) 
Bronchopneumonia * 2  1/106 (0.94%)  0/114 (0.00%) 
Cystitis * 2  1/106 (0.94%)  1/114 (0.88%) 
Genital candidiasis * 2  1/106 (0.94%)  0/114 (0.00%) 
Rhinitis * 2  1/106 (0.94%)  0/114 (0.00%) 
Sinusitis * 2  1/106 (0.94%)  0/114 (0.00%) 
Upper respiratory tract infection * 2  1/106 (0.94%)  1/114 (0.88%) 
Pneumonia bacterial * 2  0/106 (0.00%)  1/114 (0.88%) 
Bronchitis bacterial * 2  1/106 (0.94%)  0/114 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 2  2/106 (1.89%)  0/114 (0.00%) 
Ligament sprain * 2  1/106 (0.94%)  0/114 (0.00%) 
Excoriation * 2  1/106 (0.94%)  0/114 (0.00%) 
Contusion * 1  1/106 (0.94%)  1/114 (0.88%) 
Investigations     
White blood cell count decreased * 2  2/106 (1.89%)  0/114 (0.00%) 
Alanine aminotransferase increased * 2  0/106 (0.00%)  1/114 (0.88%) 
Aspartate aminotransferase increased * 2  0/106 (0.00%)  1/114 (0.88%) 
Liver function test abnormal * 2  1/106 (0.94%)  0/114 (0.00%) 
Metabolism and nutrition disorders     
Hyperlipidaemia * 2  0/106 (0.00%)  3/114 (2.63%) 
Diabetes mellitus * 2  1/106 (0.94%)  0/114 (0.00%) 
Hypercholesterolaemia * 2  1/106 (0.94%)  1/114 (0.88%) 
Musculoskeletal and connective tissue disorders     
Bursitis * 2  0/106 (0.00%)  1/114 (0.88%) 
Muscle spasms * 2  1/106 (0.94%)  0/114 (0.00%) 
Osteoporosis * 2  1/106 (0.94%)  0/114 (0.00%) 
Periarthritis * 2  0/106 (0.00%)  1/114 (0.88%) 
Trigger finger * 2  0/106 (0.00%)  1/114 (0.88%) 
Nervous system disorders     
Headache * 2  3/106 (2.83%)  0/114 (0.00%) 
Dizziness * 2  1/106 (0.94%)  0/114 (0.00%) 
Dysgeusia * 2  1/106 (0.94%)  0/114 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis * 2  1/106 (0.94%)  0/114 (0.00%) 
Urinary retention * 2  1/106 (0.94%)  0/114 (0.00%) 
Reproductive system and breast disorders     
Breast discomfort * 2  1/106 (0.94%)  0/114 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract inflammation * 2  4/106 (3.77%)  0/114 (0.00%) 
Cough * 2  1/106 (0.94%)  0/114 (0.00%) 
Interstitial lung disease * 2  1/106 (0.94%)  0/114 (0.00%) 
Pleural fibrosis * 2  0/106 (0.00%)  1/114 (0.88%) 
Pleurisy * 2  1/106 (0.94%)  0/114 (0.00%) 
Pharyngeal erythema * 2  0/106 (0.00%)  1/114 (0.88%) 
Skin and subcutaneous tissue disorders     
Rash * 2  2/106 (1.89%)  1/114 (0.88%) 
Dermatitis * 2  1/106 (0.94%)  0/114 (0.00%) 
Dermatitis contact * 2  0/106 (0.00%)  1/114 (0.88%) 
Eczema * 2  1/106 (0.94%)  0/114 (0.00%) 
Erythema * 2  1/106 (0.94%)  0/114 (0.00%) 
Pruritus * 2  0/106 (0.00%)  1/114 (0.88%) 
Rash generalized * 2  1/106 (0.94%)  0/114 (0.00%) 
Seborrheic dermatitis * 2  1/106 (0.94%)  0/114 (0.00%) 
Vascular disorders     
Hypertension * 2  1/106 (0.94%)  2/114 (1.75%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA/J Ver. 15.1
2
Term from vocabulary, MedDRA 15.1
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
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01163292     History of Changes
Other Study ID Numbers: P12-069
First Submitted: July 14, 2010
First Posted: July 15, 2010
Results First Submitted: October 18, 2013
Results First Posted: December 11, 2013
Last Update Posted: July 6, 2018