Back to resultsStudy of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)
Primary Purpose
Peripheral Spondyloarthritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Adalimumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Spondyloarthritis focused on measuring peripheral spondyloarthritis, adalimumab, humira
Eligibility Criteria
Inclusion Criteria:
- Adult participants who had inadequate response to >= 2 non-steroidal anti-inflammatories (NSAIDs)
- Participants who had arthritis or enthesitis or dactylitis plus: met spondyloarthritis clinical criteria
- Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit were Negative
- Ability to administer subcutaneous injections
- General good health
Exclusion Criteria:
- Prior anti-tumor necrosis factor (TNF) therapy
- Psoriasis or Psoriatic Arthritis
- Fulfillment of modified New York criteria for Ankylosing Spondylitis
- Recent infection requiring treatment
- Significant medical events or conditions that had put patients at risk for participation
- Female participants who were pregnant or breast-feeding or considering becoming pregnant during the study
- History of cancer, except successfully treated skin cancer
- Recent history of drug or alcohol abuse
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Double-blind (DB) Adalimumab
Double-blind Placebo
Double-blind Adalimumab / Open-label Adalimumab
Double-blind Placebo / Open-label Adalimumab
Arm Description
Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.
Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.
Outcomes
Primary Outcome Measures
Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12
Percentage of participants achieving the following composite response at Week 12: >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in Patient Global Assessment (PTGA) of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms; >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in PTGA - Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain; and >= 40% improvement from Baseline in at least 1 of the following 3 criteria: swollen joint count (76 joints) and tender joint count (78 joints); total enthesitis count; or total dactylitis count. Non-responder imputation: missing response was imputed as non-response.
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.
Secondary Outcome Measures
Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12
A VAS was to be used for the Physician Global Assessment (PGA) of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. Last observation carried forward (LOCF): missing values were imputed using the last non-missing post-baseline value prior to the missing value.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12
The BASDAI was to be completed at the designated study visits. The participant was to assess his/her disease activity using the BASDAI which consisted of a VAS scale used to answer 6 questions (Q1 through Q6) pertaining to symptoms experienced by the participant for the past week. Each question on the BASDAI was reported in centimeters (0 [none] to 10 [very severe] with one question's possible answers being in time increments [0 hours to ≥ 2 hours]). The overall BASDAI score ranges from 0 to 10 cm and was calculated as follows: BASDAI Score = 0.2 × (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). Lower scores indicate less disease activity. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.
Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12
The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.
Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12
The Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) is a 36-item generic health-related quality of life measure to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12
Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) or absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Change From Baseline in Leeds Enthesitis Index at Week 12
Assessment of enthesitis was performed in the following 6 domains: left and right lateral epicondyle, left and right medial femoral condyle, left and right Achilles tendon insertion. Tenderness at each site was quantified on a dichotomous basis: Each domain was graded for the presence (1) and absence (0) of tenderness yielding total Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12
Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was quantified on a dichotomous basis. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (worst possible score; 16 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Change From Baseline in Dactylitis at Week 12
Assessment of the presence or absence of dactylitis as well as grading of tenderness and swelling in all 20 of the participants' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranging from 0 (no digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Change From Baseline in Tender Joint Count (TJC) at Week 12
Seventy-eight joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible TJC score of 0 (0 joints with tenderness) to 78 (worst possible score/78 joints with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Change From Baseline in Swollen Joint Count (SJC) at Week 12
Seventy-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score SJC of 0 (0 joints with swelling) to 76 (worst possible score/76 joints with swelling). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
The ASDAS is a continuous disease activity score: low score indicates lower disease activity and higher values indicate higher disease activity. The score ranges from 0 to no defined upper limit. It is categorized into 4 disease activity states based on score: inactive disease (< 1.3), moderate (≥ 1.3 to < 2.1), high (≥ 2.1 to ≤ 3.5), and very high (> 3.5). Clinically important and major improvements in ASDAS are defined as a reduction from Baseline of ≥ 1.1 and ≥ 2.0 points, respectively. Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Full Information
NCT ID
NCT01064856
First Posted
February 5, 2010
Last Updated
July 2, 2021
Sponsor
AbbVie (prior sponsor, Abbott)
1. Study Identification
Unique Protocol Identification Number
NCT01064856
Brief Title
Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)
Official Title
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Peripheral Spondyloarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open label (OL) safety and efficacy assessments in participants with non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral spondyloarthritis (SpA) who have had an inadequate response to >= 2 non-steroidal anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for, NSAIDs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Spondyloarthritis
Keywords
peripheral spondyloarthritis, adalimumab, humira
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Double-blind (DB) Adalimumab
Arm Type
Experimental
Arm Description
Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
Arm Title
Double-blind Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Arm Title
Double-blind Adalimumab / Open-label Adalimumab
Arm Type
Experimental
Arm Description
Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.
Arm Title
Double-blind Placebo / Open-label Adalimumab
Arm Type
Placebo Comparator
Arm Description
Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing matching placebo for adalimumab. Study drug was SC self-administered eow at approximately the same time of day.
Primary Outcome Measure Information:
Title
Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12
Description
Percentage of participants achieving the following composite response at Week 12: >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in Patient Global Assessment (PTGA) of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms; >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in PTGA - Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain; and >= 40% improvement from Baseline in at least 1 of the following 3 criteria: swollen joint count (76 joints) and tender joint count (78 joints); total enthesitis count; or total dactylitis count. Non-responder imputation: missing response was imputed as non-response.
Time Frame
Week 12
Title
Number of Participants With Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.
Time Frame
Baseline (day of first study drug administration) through Week 156 plus 70 days
Secondary Outcome Measure Information:
Title
Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12
Description
A VAS was to be used for the Physician Global Assessment (PGA) of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. Last observation carried forward (LOCF): missing values were imputed using the last non-missing post-baseline value prior to the missing value.
Time Frame
Baseline (last measurement prior to first DB dose), Week 12
Title
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12
Description
The BASDAI was to be completed at the designated study visits. The participant was to assess his/her disease activity using the BASDAI which consisted of a VAS scale used to answer 6 questions (Q1 through Q6) pertaining to symptoms experienced by the participant for the past week. Each question on the BASDAI was reported in centimeters (0 [none] to 10 [very severe] with one question's possible answers being in time increments [0 hours to ≥ 2 hours]). The overall BASDAI score ranges from 0 to 10 cm and was calculated as follows: BASDAI Score = 0.2 × (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). Lower scores indicate less disease activity. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.
Time Frame
Baseline (last measurement prior to first DB dose), Week 12
Title
Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12
Description
The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.
Time Frame
Baseline (last measurement prior to first DB dose), Week 12
Title
Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12
Description
The Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) is a 36-item generic health-related quality of life measure to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.
Time Frame
Baseline (last measurement prior to first DB dose), Week 12
Title
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12
Description
Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) or absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Time Frame
Baseline (last measurement prior to first DB dose), Week 12
Title
Change From Baseline in Leeds Enthesitis Index at Week 12
Description
Assessment of enthesitis was performed in the following 6 domains: left and right lateral epicondyle, left and right medial femoral condyle, left and right Achilles tendon insertion. Tenderness at each site was quantified on a dichotomous basis: Each domain was graded for the presence (1) and absence (0) of tenderness yielding total Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Time Frame
Baseline (last measurement prior to first DB dose), Week 12
Title
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12
Description
Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was quantified on a dichotomous basis. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (worst possible score; 16 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Time Frame
Baseline (last measurement prior to first DB dose), Week 12
Title
Change From Baseline in Dactylitis at Week 12
Description
Assessment of the presence or absence of dactylitis as well as grading of tenderness and swelling in all 20 of the participants' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranging from 0 (no digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Time Frame
Baseline (last measurement prior to first DB dose), Week 12
Title
Change From Baseline in Tender Joint Count (TJC) at Week 12
Description
Seventy-eight joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible TJC score of 0 (0 joints with tenderness) to 78 (worst possible score/78 joints with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Time Frame
Baseline (last measurement prior to first DB dose), Week 12
Title
Change From Baseline in Swollen Joint Count (SJC) at Week 12
Description
Seventy-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score SJC of 0 (0 joints with swelling) to 76 (worst possible score/76 joints with swelling). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Time Frame
Baseline (last measurement prior to first DB dose), Week 12
Title
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
Description
The ASDAS is a continuous disease activity score: low score indicates lower disease activity and higher values indicate higher disease activity. The score ranges from 0 to no defined upper limit. It is categorized into 4 disease activity states based on score: inactive disease (< 1.3), moderate (≥ 1.3 to < 2.1), high (≥ 2.1 to ≤ 3.5), and very high (> 3.5). Clinically important and major improvements in ASDAS are defined as a reduction from Baseline of ≥ 1.1 and ≥ 2.0 points, respectively. Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
Time Frame
Baseline (last measurement prior to first DB dose), Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult participants who had inadequate response to >= 2 non-steroidal anti-inflammatories (NSAIDs)
Participants who had arthritis or enthesitis or dactylitis plus: met spondyloarthritis clinical criteria
Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit were Negative
Ability to administer subcutaneous injections
General good health
Exclusion Criteria:
Prior anti-tumor necrosis factor (TNF) therapy
Psoriasis or Psoriatic Arthritis
Fulfillment of modified New York criteria for Ankylosing Spondylitis
Recent infection requiring treatment
Significant medical events or conditions that had put patients at risk for participation
Female participants who were pregnant or breast-feeding or considering becoming pregnant during the study
History of cancer, except successfully treated skin cancer
Recent history of drug or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Ho Song, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
25545240
Citation
Mease P, Sieper J, Van den Bosch F, Rahman P, Karunaratne PM, Pangan AL. Randomized controlled trial of adalimumab in patients with nonpsoriatic peripheral spondyloarthritis. Arthritis Rheumatol. 2015 Apr;67(4):914-23. doi: 10.1002/art.39008.
Results Reference
background
PubMed Identifier
32937016
Citation
Coates LC, Abraham S, Tillett W, Mease PJ, Ramiro S, Wu T, Wang X, Pangan AL, Song IH. Performance and Predictors of Minimal Disease Activity Response in Patients With Peripheral Spondyloarthritis Treated With Adalimumab. Arthritis Care Res (Hoboken). 2022 Feb;74(2):259-267. doi: 10.1002/acr.24442. Epub 2021 Dec 29.
Results Reference
derived
PubMed Identifier
28298558
Citation
Mease PJ, Van den Bosch F, Sieper J, Xia Y, Pangan AL, Song IH. Performance of 3 Enthesitis Indices in Patients with Peripheral Spondyloarthritis During Treatment with Adalimumab. J Rheumatol. 2017 May;44(5):599-608. doi: 10.3899/jrheum.160387. Epub 2017 Mar 15.
Results Reference
derived
PubMed Identifier
26245756
Citation
Turina MC, Ramiro S, Baeten DL, Mease P, Paramarta JE, Song IH, Pangan AL, Landewe R. A psychometric analysis of outcome measures in peripheral spondyloarthritis. Ann Rheum Dis. 2016 Jul;75(7):1302-7. doi: 10.1136/annrheumdis-2014-207235. Epub 2015 Aug 5.
Results Reference
derived
Links:
URL
http://rxabbvie.com
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Learn more about this trial
Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)
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