ClinicalTrials.gov
ClinicalTrials.gov Menu

A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis (RADAR)

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: NCT01162421
Recruitment Status : Completed
First Posted : July 14, 2010
Results First Posted : November 1, 2016
Last Update Posted : November 1, 2016
Sponsor:
Collaborator:
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Biological: adalimumab
Drug: Methotrexate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Standard of Care Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Early Adalimumab Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.

Participant Flow:   Overall Study
    Standard of Care   Early Adalimumab
STARTED   37   40 
COMPLETED   29   27 
NOT COMPLETED   8   13 
Did not receive study drug                2                1 
Adverse Event                2                5 
Lost to Follow-up                0                2 
Lack of Efficacy                2                2 
Not specified                2                3 



  Baseline Characteristics

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.
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug.

Reporting Groups
  Description
Standard of Care Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Early Adalimumab Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Total Total of all reporting groups

Baseline Measures
   Standard of Care   Early Adalimumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   39   74 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.8  (10.46)   51.9  (11.55)   52.8  (11.01) 
Age, Customized 
[Units: Participants]
     
< 65 years   30   34   64 
>/= 65 years   5   5   10 
Gender 
[Units: Participants]
     
Female   24   26   50 
Male   11   13   24 


  Outcome Measures

1.  Primary:   Percentage of Participants With No Radiographic Progression at Month 12   [ Time Frame: Baseline, Month 12 ]

2.  Secondary:   Percentage of Participants With No Radiographic Progression at Month 6 and Month 24   [ Time Frame: Baseline, Month 6, Month 24 ]

3.  Secondary:   Change From Baseline in mTSS at Months 6, 12 and 24   [ Time Frame: Baseline, Month 6, Month 12, Month 24 ]

4.  Secondary:   Percentage of Participants With Rapid Radiographic Progression at Month 12   [ Time Frame: Month 12 ]

5.  Secondary:   Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

6.  Secondary:   Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

7.  Secondary:   Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Months 3, 6, 9, 12, 18, 24 ]

8.  Secondary:   Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

9.  Secondary:   Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

10.  Secondary:   Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

11.  Secondary:   Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

12.  Secondary:   Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

13.  Secondary:   Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

14.  Secondary:   Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

15.  Secondary:   Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

16.  Secondary:   Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

17.  Secondary:   Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Months 3, 6, 9, 12, 18, 24 ]

18.  Secondary:   Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Months 3, 6, 9, 12, 18, 24 ]

19.  Secondary:   Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Months 3, 6, 9, 12, 18, 24 ]

20.  Secondary:   Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Months 3, 6, 9, 12, 18, 24 ]

21.  Secondary:   Percentage of Participants With Flare-Up After Remission by Month 24   [ Time Frame: Month 24 ]

22.  Secondary:   Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

23.  Secondary:   Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Months 3, 6, 9, 12, 18, 24 ]

24.  Secondary:   Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Months 3, 6, 9, 12, 18, 24 ]

25.  Secondary:   Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

26.  Secondary:   Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Months 3, 6, 9, 12, 18, 24 ]

27.  Secondary:   Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

28.  Secondary:   Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

29.  Secondary:   Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

30.  Secondary:   Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Baseline, Months 3, 6, 9, 12, 18, 24 ]

31.  Secondary:   Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24   [ Time Frame: Months 3, 6, 9, 12, 18, 24 ]

32.  Secondary:   Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline   [ Time Frame: Baseline ]

33.  Secondary:   HCR: Medical Insurance at Final Visit   [ Time Frame: Final Visit (up to Month 24) ]

34.  Secondary:   HCR: Health Care for RA in the Past 4 Weeks at Baseline   [ Time Frame: Baseline ]

35.  Secondary:   HCR: Health Care for RA in the Past 4 Weeks at Final Visit   [ Time Frame: Final Visit (up to Month 24) ]

36.  Secondary:   HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline   [ Time Frame: Baseline ]

37.  Secondary:   HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit   [ Time Frame: Final Visit (up to Month 24) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 Information
Organization: AbbVie
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01162421     History of Changes
Other Study ID Numbers: W12-122
First Submitted: May 25, 2010
First Posted: July 14, 2010
Results First Submitted: July 22, 2016
Results First Posted: November 1, 2016
Last Update Posted: November 1, 2016