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Trial record 34 of 2725 for:    Rheumatoid Arthritis

Assessment of the Safety of Adalimumab in Rheumatoid Arthritis Patients Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents

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ClinicalTrials.gov Identifier: NCT01783730
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : October 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Enrollment 163
Recruitment Details  
Pre-assignment Details Participants who received adalimumab treatment
Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
Hide Arm/Group Description Participants who received adalimumab treatment
Period Title: Overall Study
Started 163
Completed 157
Not Completed 6
Reason Not Completed
Failed to meet inclusion criteria             6
Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Overall Number of Baseline Participants 157
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Participants who received adalimumab treatment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants
56.5  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants
Female
103
  65.6%
Male
54
  34.4%
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 which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. Adverse events were collected from the time of informed consent until the completion of the study, up to 26 weeks.
Time Frame From baseline through week 26
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Participants who received adalimumab treatment
Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 157
Measure Type: Number
Unit of Measure: participants
40
2.Secondary Outcome
Title Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline
Hide Description The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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 at week 0
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Participants with available data
Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 121
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.61  (1.39)
3.Secondary Outcome
Title Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 4
Hide Description The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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 at week 4
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.57  (1.52)
4.Secondary Outcome
Title Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 12
Hide Description The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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 at week 12
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.96  (1.35)
5.Secondary Outcome
Title Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 24
Hide Description The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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 at week 24
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.41  (1.06)
6.Secondary Outcome
Title Percentage of Participants Achieving DAS28-4(ESR) Remission
Hide Description The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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. The percentage of participants with a DAS28 score <2.6 was documented.
Time Frame From baseline to 24 weeks
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 131
Measure Type: Number
Unit of Measure: percentage of participants
Baseline, n=121 0.0
Week 4, n=107 29.9
Week 12, n=90 45.6
Week 24, n=79 60.8
7.Secondary Outcome
Title Mean Clinical Disease Activity Index (CDAI) Score at Baseline
Hide Description The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
Time Frame at week 0
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: units on a scale
29.18  (14.38)
8.Secondary Outcome
Title Mean Clinical Disease Activity Index (CDAI) Score at Week 4
Hide Description The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
Time Frame at week 4
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.95  (9.30)
9.Secondary Outcome
Title Mean Clinical Disease Activity Index (CDAI) Score at Week 12
Hide Description The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
Time Frame at week 12
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.26  (7.73)
10.Secondary Outcome
Title Mean Clinical Disease Activity Index (CDAI) Score at Week 24
Hide Description The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
Time Frame at week 24
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 88
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.96  (4.39)
11.Secondary Outcome
Title Percentage of Participants Achieving CDAI Remission
Hide Description The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm) , and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission. The percentage of participants with a CDAI score ≤2.8 was documented.
Time Frame From baseline to 24 weeks
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
Baseline, n=138 0.7
Week 4, n=130 20.0
Week 12, n=108 35.2
Week 24, n=88 60.2
12.Secondary Outcome
Title Mean Simplified Disease Activity Index (SDAI) Score at Baseline
Hide Description The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
Time Frame at week 0
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
32.30  (16.07)
13.Secondary Outcome
Title Mean Simplified Disease Activity Index (SDAI) Score at Week 4
Hide Description The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
Time Frame at week 4
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.06  (10.20)
14.Secondary Outcome
Title Mean Simplified Disease Activity Index (SDAI) Score at Week 12
Hide Description The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
Time Frame at week 12
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.08  (9.09)
15.Secondary Outcome
Title Mean Simplified Disease Activity Index (SDAI) Score at Week 24
Hide Description The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
Time Frame at week 24
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 85
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.58  (4.93)
16.Secondary Outcome
Title Percentage of Participants Achieving SDAI Remission
Hide Description The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission. The percentage of participants with an SDAI score ≤3.3 was documented.
Time Frame From baseline to 24 weeks
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Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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Participants who received adalimumab treatment
Overall Number of Participants Analyzed 143
Measure Type: Number
Unit of Measure: percentage of participants
Baseline, n=131 0.0
Week 4, n=123 22.0
Week 12, n=103 39.8
Week 24, n=85 58.8
Time Frame Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants With High Rheumatoid Arthritis Disease Activity
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All-Cause Mortality
Participants With High Rheumatoid Arthritis Disease Activity
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participants With High Rheumatoid Arthritis Disease Activity
Affected / at Risk (%)
Total   4/157 (2.55%) 
Cardiac disorders   
Pericarditis  1  1/157 (0.64%) 
Infections and infestations   
Pyelonephritis  1  1/157 (0.64%) 
Pneumocystis jiroveci pneumonia  1  1/157 (0.64%) 
Respiratory, thoracic and mediastinal disorders   
Interstitial lung disease  1  1/157 (0.64%) 
Pleurisy  1  1/157 (0.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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Frequency Threshold for Reporting Other Adverse Events 0%
Participants With High Rheumatoid Arthritis Disease Activity
Affected / at Risk (%)
Total   36/157 (22.93%) 
Blood and lymphatic system disorders   
Lymphadenopathy  1  1/157 (0.64%) 
Gastrointestinal disorders   
Nausea  1  3/157 (1.91%) 
General disorders   
Chills  1  1/157 (0.64%) 
Injection site erythema  1  1/157 (0.64%) 
Injection site reaction  1  1/157 (0.64%) 
Oedema peripheral  1  1/157 (0.64%) 
Pyrexia  1  1/157 (0.64%) 
Unevaluable event  1  1/157 (0.64%) 
Hepatobiliary disorders   
Liver disorder  1  2/157 (1.27%) 
Immune system disorders   
Hypersensitivity  1  1/157 (0.64%) 
Infections and infestations   
Gastroenteritis  1  1/157 (0.64%) 
Herpes zoster  1  1/157 (0.64%) 
Nasopharyngitis  1  2/157 (1.27%) 
Pneumonia  1  1/157 (0.64%) 
Pulpitis dental  1  1/157 (0.64%) 
Pneumonia bacterial  1  1/157 (0.64%) 
Injury, poisoning and procedural complications   
Foot fracture  1  1/157 (0.64%) 
Investigations   
Alanine aminotransferase increased  1  4/157 (2.55%) 
Aspartate aminotransferase increased  1  2/157 (1.27%) 
Gamma-glutamyltransferase increased  1  1/157 (0.64%) 
Liver function test abnormal  1  4/157 (2.55%) 
Platelet count decreased  1  1/157 (0.64%) 
White blood cell count decreased  1  3/157 (1.91%) 
Blood beta-D-glucan increased  1  1/157 (0.64%) 
Hepatic enzyme increased  1  1/157 (0.64%) 
Hepatic enzyme abnormal  1  1/157 (0.64%) 
Mycobacterium tuberculosis complex test positive  1  1/157 (0.64%) 
Metabolism and nutrition disorders   
Hyperuricaemia  1  1/157 (0.64%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/157 (0.64%) 
Psychiatric disorders   
Dysphoria  1  1/157 (0.64%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  1/157 (0.64%) 
Pruritus  1  1/157 (0.64%) 
Rash  1  1/157 (0.64%) 
Vascular disorders   
Hypertension  1  1/157 (0.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01783730     History of Changes
Other Study ID Numbers: P13-983
First Submitted: February 1, 2013
First Posted: February 5, 2013
Results First Submitted: September 2, 2016
Results First Posted: October 26, 2016
Last Update Posted: October 26, 2016