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Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01064856
First received: February 5, 2010
Last updated: October 4, 2016
Last verified: August 2016
Results First Received: May 31, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Peripheral Spondyloarthritis
Interventions: Biological: Adalimumab
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Double-blind (DB) Adalimumab Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
Double-blind Placebo Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Double-blind Adalimumab / Open-label Adalimumab 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.
Double-blind Placebo / Open-label Adalimumab 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.

Participant Flow for 2 periods

Period 1:   Double-blind (DB) Period
    Double-blind (DB) Adalimumab   Double-blind Placebo   Double-blind Adalimumab / Open-label Adalimumab   Double-blind Placebo / Open-label Adalimumab
STARTED   84   81   0 [1]   0 [1] 
COMPLETED   82   81   0   0 
NOT COMPLETED   2   0   0   0 
Adverse Event                1                0                0                0 
Consent withdrawn by participant                1                0                0                0 
[1] This treatment group is not applicable for this period.

Period 2:   Open-label (OL) Period
    Double-blind (DB) Adalimumab   Double-blind Placebo   Double-blind Adalimumab / Open-label Adalimumab   Double-blind Placebo / Open-label Adalimumab
STARTED   0 [1]   0 [1]   82   81 
COMPLETED   0   0   56   61 
NOT COMPLETED   0   0   26   20 
Adverse Event                0                0                12                6 
Consent withdrawn by participant                0                0                5                6 
Lost to Follow-up                0                0                2                1 
Not specified                0                0                7                7 
[1] This treatment group is not applicable for this period.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug (ITT).

Reporting Groups
  Description
Double-blind (DB) Adalimumab Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
Double-blind Placebo Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Total Total of all reporting groups

Baseline Measures
   Double-blind (DB) Adalimumab   Double-blind Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 84   81   165 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.5  (10.79)   38.5  (12.77)   40.6  (11.94) 
Gender 
[Units: Participants]
     
Female   48   42   90 
Male   36   39   75 
Tender Joint Count (78 Joints) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 12.95  (12.79)   13.62  (16.10)   13.28  (14.46) 
[1] 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 score of 0 (0 joints with tenderness) to 78 (worst possible score/ 78 joints with tenderness).
Swollen Joint Count (76 Joints) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.12  (5.58)   7.31  (7.99)   6.70  (6.87) 
[1] 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 of 0 (0 joints with swelling) to 76 (worst possible score/ 76 joints with swelling).
Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.13  (3.60)   3.59  (3.39)   3.36  (3.50) 
[1] Assessment of enthesitis was performed in 7 domains. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness).
Leeds Enthesitis Index [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.49  (1.66)   1.42  (1.61)   1.45  (1.63) 
[1] Assessment of enthesitis was performed in 6 domains. 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).
Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.83  (4.03)   4.05  (3.78)   3.94  (3.90) 
[1] Assessment of enthesitis was performed in 16 domains. 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).
Total Enthesitis Count [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.73  (6.95)   7.33  (6.69)   7.02  (6.81) 
[1] Total enthesitis count in the sum of all unique, individual enthesis location included in the Leeds, SPARCC and MASES entheses indices. Scores range from 0 (0 sites with enthesitis) to 29 (29 sites with enthesitis).
Patient Global Assessment (PTGA) of Disease Activity [1] 
[Units: Mm]
Mean (Standard Deviation)
 65.24  (15.22)   66.43  (15.86)   65.82  (15.50) 
[1] PTGA of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms.
PTGA – Pain [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 64.30  (14.03)   65.60  (15.89)   64.94  (14.94) 
[1] PTGA – Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain.
Physician Global Assessment (PGA) of Disease Activity [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 60.29  (15.53)   57.02  (14.98)   58.68  (15.31) 
[1] PGA of Disease Activity as measured by a 100 mm VAS where 0=no symptoms and 100=maximum symptoms.
Ankylosing Spondylitis Disease Activity Score (ASDAS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.92  (0.84)   3.06  (0.80)   2.99  (0.82) 
[1] 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). One participant in the Placebo arm did not have a baseline ASDAS assessment.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.68  (1.74)   5.57  (1.58)   5.62  (1.66) 
[1] The BASDAI consisted of a VAS scale used to answer 6 questions 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. Lower scores indicate less disease activity.
Dactylitis Count [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.35  (0.94)   0.65  (1.25)   0.50  (1.11) 
[1] 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 (0 digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). One participant in the Double-blind (DB) Adalimumab arm did not have a baseline dactylitis count.
Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 34.56  (7.93)   34.48  (7.62)   34.52  (7.76) 
[1] The 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. Scores range from 0 to 100. Higher scores indicate a better health state.


  Outcome Measures
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1.  Primary:   Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12   [ Time Frame: Week 12 ]

2.  Primary:   Number of Participants With Adverse Events   [ Time Frame: Baseline (day of first study drug administration) through Week 156 plus 70 days ]

3.  Secondary:   Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12   [ Time Frame: Baseline (last measurement prior to first DB dose), Week 12 ]

4.  Secondary:   Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12   [ Time Frame: Baseline (last measurement prior to first DB dose), Week 12 ]

5.  Secondary:   Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12   [ Time Frame: Baseline (last measurement prior to first DB dose), Week 12 ]

6.  Secondary:   Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12   [ Time Frame: Baseline (last measurement prior to first DB dose), Week 12 ]

7.  Secondary:   Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12   [ Time Frame: Baseline (last measurement prior to first DB dose), Week 12 ]

8.  Secondary:   Change From Baseline in Leeds Enthesitis Index at Week 12   [ Time Frame: Baseline (last measurement prior to first DB dose), Week 12 ]

9.  Secondary:   Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12   [ Time Frame: Baseline (last measurement prior to first DB dose), Week 12 ]

10.  Secondary:   Change From Baseline in Dactylitis at Week 12   [ Time Frame: Baseline (last measurement prior to first DB dose), Week 12 ]

11.  Secondary:   Change From Baseline in Tender Joint Count (TJC) at Week 12   [ Time Frame: Baseline (last measurement prior to first DB dose), Week 12 ]

12.  Secondary:   Change From Baseline in Swollen Joint Count (SJC) at Week 12   [ Time Frame: Baseline (last measurement prior to first DB dose), Week 12 ]

13.  Secondary:   Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12   [ Time Frame: Baseline (last measurement prior to first DB dose), Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: AbbVie
phone: 800-633-9110


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01064856     History of Changes
Other Study ID Numbers: M10-883
2009-014567-39 ( EudraCT Number )
Study First Received: February 5, 2010
Results First Received: May 31, 2016
Last Updated: October 4, 2016
Health Authority: Australia: Human Research Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Spain: Agencia Española de Medicamentos y Productos Sanitarios