Special Investigation in Patients With Rheumatoid Arthritis (HOPEFUL III Study), a Follow-up Survey of Study P12-069

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01346501
First received: April 29, 2011
Last updated: February 15, 2016
Last verified: February 2016
  Purpose
The main objective of this study was to determine the ability to maintain response after discontinuation of adalimumab treatment and the secondary objective was to determine radiographic progression in participants participating in the study, including the percentage who displayed minimal progression.

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Extended Observational Study (P12-707: HOPEFUL III Study) of Follow-up Survey (P12-069: HOPEFUL II Study) 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:
  • Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment [ Time Frame: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, and Week 156 ] [ Designated as safety issue: No ]
    The DAS28-CRP, a combined index that measured Rheumatoid Arthritis (RA) disease activity, was calculated based on the number of tender joint count (28 joints), the number of swollen joint count (28 joints), overall disease activity (using visual analog scale (VAS)), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP). The DAS28-CRP scores ranged from 0 (no disease activity) to 9 (maximal disease activity); decrease in DAS28-CRP score indicated improvement of disease. In participants who discontinued treatment with adalimumab after sustained low disease activity (defined as DAS28-CRP score <3.2) in study M06-859, the percentage of participants who maintained DAS28-CRP score < 3.2 without disease flare (defined as DAS28-CRP score ≥ 3.2) during studies P12-069 and P12-707 was calculated.

  • Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3) [ Time Frame: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208 ] [ Designated as safety issue: No ]
    MMP-3, a proteolytic enzyme that plays a pivotal role in joint destruction in RA was assessed during the study. MMP-3 serum level < 121 ng/mL in men and < 59.7 ng/mL in women was considered as the normal value. Data are presented as the percentage of participants with MMP-3 serum level greater than the normal value.

  • Mean Health Assessment Questionnaire (HAQ) Score [ Time Frame: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208 ] [ Designated as safety issue: No ]
    The HAQ score was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ score +/- standard deviation with negative scores indicating improvement.


Secondary Outcome Measures:
  • Percentage of Participants With Modified Total Sharp Score (mTSS) ≤ 0.5 and ≤ 1.5 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The mTSS, a method of assessing radiographs, was used to evaluate the level of joint destruction by disease. Digitized X-rays of hands and feet were obtained and scored on a scale ranging from 0 [no damage] to 5 [complete collapse or total destruction of joint] for erosion and 0 [no damage] to 4 [complete luxation of joint] for joint space narrowing. The scores on each task were summed and averaged to derive the total mTSS score ranging from 0 [normal] to 380 [maximal disease]. Large positive change in mTSS indicated disease progression; small positive/no change indicated slowing/halting of disease progression. The mTSS score ≤ 0.5 was defined as minimal radiographic progression. Data are presented as the percentage of the participants with mTSS ≤ 0.5 and ≤ 1.5 at the end of third year of the observation period (at Week 104 of P12-707).

  • Percentage of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions [ Time Frame: From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years ] [ Designated as safety issue: Yes ]
    Adverse drug reactions (serious and non-serious) are adverse events for which the causal relationship between adalimumab and the event could not be ruled out. Adverse event was defined as any untoward or unintended medical occurrences (including abnormal laboratory findings), signs/symptoms, or diseases of the participant receiving adalimumab, regardless of causality of adalimumab treatment. Data are presented as percentage of participants.


Enrollment: 172
Study Start Date: April 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adalimumab

Participants with Rheumatoid Arthritis (RA) who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.

Other name for adalimumab is Humira.

Non-adalimumab
Patients who discontinued adalimumab treatment after completion of the study M06-859.

Detailed Description:
This was a two-arm, multi-center, Post Marketing Observational Study (PMOS) conducted in Japanese participants with Rheumatoid Arthritis (RA) who continued the one year observational period of study P12-069 (HOPEFUL II study; NCT01163292) and provided informed consent to participate in study P12-707 (HOPEFUL III study; NCT01346501), after completion of study M06-859 (HOPEFUL I study; NCT00870467). The study P12-707 provided an additional two years of observation for those participants who participated in study P12-069.
  Eligibility

Ages Eligible for Study:   20 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with Rheumatoid Arthritis (RA) who continued the one year observational period of study P12-069 and provided informed consent to participate in study P12-707.
Criteria

Inclusion Criteria:

Participants with RA who continued the one year observational period of study P12-069 and provided informed consent to participate in study P12-707.

Exclusion Criteria:

Participants with RA who used biological agents other than adalimumab in the one year observational period of study P12-069.

  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: NCT01346501

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Sarina Kurimoto AbbVie GK
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01346501     History of Changes
Other Study ID Numbers: P12-707 
Study First Received: April 29, 2011
Results First Received: November 25, 2015
Last Updated: February 15, 2016
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
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 29, 2016