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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 Description
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Brief Summary:
The present survey was conducted to evaluate the effectiveness and safety of treatment with adalimumab during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859) in participants who continued treatment with adalimumab for 52 weeks.

Condition or disease
Rheumatoid Arthritis

Detailed Description:
This survey was conducted to assess the risk and benefit of continuing or discontinuing biological therapy with adalimumab (Humira) during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859).
Study Design
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Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Humira 40 mg/0.8 mL Syringe for Subcutaneous Injection - 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)]
Study Start Date : March 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Groups and Cohorts
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Group/Cohort
Adalimumab
Participants who continued adalimumab treatment after completion of Study NCT00870467 (M06-859)
Non-Adalimumab
Participants who discontinued adalimumab treatment after completion of Study NCT00870467(M06-859)


Outcome Measures
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Primary Outcome Measures :
  1. Disease Activity Score (DAS28) [ Time Frame: Weeks 0, 26, and 52 ]
    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.


Secondary Outcome Measures :
  1. Matrix Metalloprotease-3 (MMP-3) [ Time Frame: Weeks 0, 26, and 52 ]
    MMP-3 level in serum. Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female)

  2. Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52 [ Time Frame: Week 0 to Week 52 ]
    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.

  3. Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Weeks 0, 26, and 52 ]
    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.

  4. Number of Participants With Adverse Events (AEs) [ Time Frame: Week 0 to Week 52 ]
    Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study.
Criteria

Inclusion Criteria:

  • The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study and provided informed consent to participate in the present follow-up survey.

Exclusion Criteria:

  • Participants who used biological agents other than adalimumab after the period of treatment in the NCT00870467(M06-859) study were excluded from the present follow-up study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163292


Locations
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Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
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Study Director: Aki Kuroki AbbVie GK.
More Information
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Additional Information:

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

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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01163292    
Other Study ID Numbers: P12-069
First Posted: July 15, 2010    Key Record Dates
Results First Posted: December 11, 2013
Last Update Posted: July 6, 2018
Last Verified: December 2013
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases