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

An observational study of Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 20 to 99 years
Conditions the study is for: Rheumatoid Arthritis
How many people: 172 participants
Where: No sites listed yet
Study dates: Apr 2011to Nov 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

About this study

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)

Read the 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.

Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01346501
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment
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.
Measured: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, and Week 156
Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)
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.
Measured: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208
Mean Health Assessment Questionnaire (HAQ) Score
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.
Measured: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208

Secondary outcomes (2)

Percentage of Participants With Modified Total Sharp Score (mTSS) ≤ 0.5 and ≤ 1.5
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).
Measured: 3 years
Percentage of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions
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.
Measured: From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Nov 2014

First posted3 May 2011 (estimated)
Study startApr 2011
Primary completionNov 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01346501
Sponsor's protocol ID: P12-707
Status last verified: Feb 2016
First submitted: 29 Apr 2011
Last updated: 11 Mar 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Tanaka Y, Yamanaka H, Ishiguro N, Miyasaka N, Kawana K, Kimura J, Agata N, Takeuchi T. Low disease activity for up to 3 years after adalimumab discontinuation in patients with early rheumatoid arthritis: 2-year results of the HOPEFUL-3 Study. Arthritis Res Ther. 2017 Mar 14;19(1):56. doi: 10.1186/s13075-017-1264-6.
PubMed 28288682

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01346501
Acronym / sponsor ID: P12-707
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 3 May 2011 (estimated)
Results: Posted 11 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 20 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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
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
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
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.

2 secondary outcomes

Percentage of Participants With Modified Total Sharp Score (mTSS) ≤ 0.5 and ≤ 1.5
Time frame: 3 years
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

Results and safety

Results posted to the registry on 11 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adalimumab	79	68
Non-adalimumab	93	80

Primary outcome: 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. Number. Unit: Percentage of participants

Measure	Non-adalimumab n = 77
Week 0	100.0
Week 26	77.9
Week 52	71.4
Week 78	63.6
Week 104	58.4
Week 130	54.5
Week 156	45.5

Population analysed: The effectiveness analysis set was defined as all participants who had evaluable DAS28-CRP score during studies P12-069 and P12-707.

Primary outcome: 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. Number. Unit: Percentage of participants

Measure	Adalimumab n = 77	Non-adalimumab n = 84
Week 0	79.2	67.9
Week 26 (N=77, 83)	53.2	38.6
Week 52	37.7	27.4
Week 78 (N=62, 57)	38.7	36.8
Week 104 (N=58, 66)	19.0	42.4
Week 130 (N=40, 46)	25.0	32.6
Week 156 (N=38, 52)	28.9	32.7
Week 182 (N=35, 38)	20.0	23.7

Population analysed: The effectiveness analysis set was defined as all participants who had evaluable MMP-3 score during studies P12-069 and P12-707.

Primary outcome: 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. Mean (Standard Deviation). Unit: Score on a scale

Measure	Adalimumab n = 72	Non-adalimumab n = 83
Week 0	1.19 (0.70)	1.04 (0.71)
Week 26 (N=72, 82)	0.48 (0.55)	0.42 (0.46)
Week 52	0.27 (0.35)	0.25 (0.34)
Week 78 (N=45, 48)	0.13 (0.26)	0.18 (0.32)
Week 104 (N=55, 62)	0.21 (0.30)	0.23 (0.36)
Week 130 (N=30, 44)	0.18 (0.33)	0.16 (0.27)
Week 156 (N=28, 51)	0.17 (0.35)	0.30 (0.49)
Week 182 (N=26, 33)	0.20 (0.25)	0.26 (0.43)

Population analysed: The effectiveness analysis set was defined as all participants who had evaluable HAQ score during studies P12-069 and P12-707.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adalimumab	3 of 79 (3.8%)	25 of 79 (31.6%)	Not reported
Non-adalimumab	1 of 22 (4.5%)	9 of 22 (40.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28288682Tanaka Y, Yamanaka H, Ishiguro N, Miyasaka N, Kawana K, Kimura J, Agata N, Takeuchi T. Low disease activity for up to 3 years after adalimumab discontinuation in patients with early rheumatoid arthritis: 2-year results of the HOPEFUL-3 Study. Arthritis Res Ther. 2017 Mar 14;19(1):56. doi: 10.1186/s13075-017-1264-6.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sarina Kurimoto study director

AbbVie

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01346501, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.