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) (HOPE 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01163292
First received: July 14, 2010
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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
Rheumatoid Arthritis

Study Type: Observational
Study Design: 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)]

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Disease Activity Score (DAS28) [ Time Frame: Weeks 0, 26, and 52 ] [ Designated as safety issue: No ]
    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:
  • Matrix Metalloprotease-3 (MMP-3) [ Time Frame: Weeks 0, 26, and 52 ] [ Designated as safety issue: No ]
    MMP-3 level in serum. Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female)

  • Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52 [ Time Frame: Week 0 to Week 52 ] [ Designated as safety issue: No ]
    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.

  • Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Weeks 0, 26, and 52 ] [ Designated as safety issue: No ]
    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.

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


Enrollment: 220
Study Start Date: March 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163292

  Show 75 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Aki Kuroki AbbVie GK
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01163292     History of Changes
Other Study ID Numbers: P12-069
Study First Received: July 14, 2010
Results First Received: October 18, 2013
Last Updated: December 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 01, 2014