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))

An observational study of Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott) at 75 sites in Japan.

Completed

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

Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Rheumatoid Arthritis
How many people: 220 participants
Where: 75 sitesJapan
Study dates: Mar 2010to Oct 2012
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

75 sites in 1 country.

City, postcode or hospital

75 sites in 1 country

Japan75 sites

Site Reference ID/Investigator# 54680
Anjo
Site Reference ID/Investigator# 54677
Aomori
Site Reference ID/Investigator# 54516
Chiba
Site Reference ID/Investigator# 54660
Chiba
Site Reference ID/Investigator# 54683
Chiba
Site Reference ID/Investigator# 54521
Fukuoka
Site Reference ID/Investigator# 39854
Gifu
Site Reference ID/Investigator# 54666
Hamamatsu
Site Reference ID/Investigator# 54682
Hiroshima
Site Reference ID/Investigator# 54669
Hyōgo
Site Reference ID/Investigator# 54674
Hyōgo
Site Reference ID/Investigator# 54653
Ibaraki
Site Reference ID/Investigator# 54670
Kagoshima
Site Reference ID/Investigator# 54692
Kagoshima
Site Reference ID/Investigator# 54679
Kawagoe
Site Reference ID/Investigator# 59580
Kawagoe
Site Reference ID/Investigator# 54662
Kawasaki
Site Reference ID/Investigator# 54693
Kirishima
Site Reference ID/Investigator# 54671
Kitakyushu
Site Reference ID/Investigator# 54643
Kumamoto
Site Reference ID/Investigator# 59583
Kyoto
Site Reference ID/Investigator# 59582
Maebashi
Site Reference ID/Investigator# 39849
Matsumoto
Site Reference ID/Investigator# 54520
Matsuyama
Site Reference ID/Investigator# 54644
Miyazaki
Site Reference ID/Investigator# 54645
Morioka
Site Reference ID/Investigator# 54654
Nagano
Site Reference ID/Investigator# 54656
Nagaoka
Site Reference ID/Investigator# 63052
Nagasaki
Site Reference ID/Investigator# 54667
Nagoya
Site Reference ID/Investigator# 54673
Nagoya
Site Reference ID/Investigator# 54649
Nara
Site Reference ID/Investigator# 39844
Niigata
Site Reference ID/Investigator# 54675
Ōita
Site Reference ID/Investigator# 39847
Okayama
Site Reference ID/Investigator# 54681
Okayama
Site Reference ID/Investigator# 39846
Osaka
Site Reference ID/Investigator# 54518
Osaka
Site Reference ID/Investigator# 54646
Rifu
Site Reference ID/Investigator# 54661
Sagamihara, Kanagawa
Site Reference ID/Investigator# 54514
Saitama
Site Reference ID/Investigator# 54689
Saitama
Site Reference ID/Investigator# 25922
Sapporo
Site Reference ID/Investigator# 39850
Sapporo
Site Reference ID/Investigator# 54651
Sapporo
Site Reference ID/Investigator# 54652
Sapporo
Site Reference ID/Investigator# 54522
Sasebo
Site Reference ID/Investigator# 54650
Setouchi
Site Reference ID/Investigator# 39851
Shimotsuke
Site Reference ID/Investigator# 39845
Shizuoka
Site Reference ID/Investigator# 54517
Shizuoka
Site Reference ID/Investigator# 59579
Takamatsu
Site Reference ID/Investigator# 54655
Takasaki
Site Reference ID/Investigator# 54519
Tenri
Site Reference ID/Investigator# 54515
Tokorozawa
Site Reference ID/Investigator# 39842
Tokyo
Site Reference ID/Investigator# 39852
Tokyo
Site Reference ID/Investigator# 39853
Tokyo
Site Reference ID/Investigator# 54647
Tokyo
Site Reference ID/Investigator# 54657
Tokyo
Site Reference ID/Investigator# 54658
Tokyo
Site Reference ID/Investigator# 54678
Tokyo
Site Reference ID/Investigator# 54688
Tokyo
Site Reference ID/Investigator# 59581
Tokyo
Site Reference ID/Investigator# 54672
Tomigusuku
Site Reference ID/Investigator# 54648
Toyama
Site Reference ID/Investigator# 54691
Toyama
Site Reference ID/Investigator# 54690
Toyoake
Site Reference ID/Investigator# 54676
Toyohashi
Site Reference ID/Investigator# 54668
Tsu
Site Reference ID/Investigator# 39843
Yokohama
Site Reference ID/Investigator# 54663
Yokohama
Site Reference ID/Investigator# 54664
Yokohama
Site Reference ID/Investigator# 54665
Yokohama
Site Reference ID/Investigator# 54659
Yotsukaidō

Other trials in Japan

About this study

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)]

Read the 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).

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 NCT01163292
Study group	Role	What they receive
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)

What is being measured

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

Disease Activity Score (DAS28)
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.
Measured: Weeks 0, 26, and 52

Secondary outcomes (4)

Matrix Metalloprotease-3 (MMP-3)
MMP-3 level in serum. Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female)
Measured: Weeks 0, 26, and 52
Modified Total Sharp Score (mTSS) Change From 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.
Measured: Week 0 to Week 52
Health Assessment Questionnaire Disability Index (HAQ-DI)
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.
Measured: Weeks 0, 26, and 52
Number of Participants With Adverse Events (AEs)
Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.
Measured: Week 0 to Week 52

Timeline

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

Mar 2010Oct 2012

First posted15 Jul 2010 (estimated)
Study startMar 2010
Primary completionOct 2012
Study completionOct 2012

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: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01163292
Sponsor's protocol ID: P12-069
Status last verified: Dec 2013
First submitted: 14 Jul 2010
Last updated: 6 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tanaka Y, Yamanaka H, Ishiguro N, Miyasaka N, Kawana K, Hiramatsu K, Takeuchi T. Adalimumab discontinuation in patients with early rheumatoid arthritis who were initially treated with methotrexate alone or in combination with adalimumab: 1 year outcomes of the HOPEFUL-2 study. RMD Open. 2016 Feb 18;2(1):e000189. doi: 10.1136/rmdopen-2015-000189. eCollection 2016.
PubMed 26925252

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?

See locations

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Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Recruiting
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Rheumatoid Arthritis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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)]
ClinicalTrials.gov ID: NCT01163292
Acronym / sponsor ID: P12-069
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 15 Jul 2010 (estimated)
Results: Posted 11 Dec 2013

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 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)

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

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

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.

4 secondary outcomes

Matrix Metalloprotease-3 (MMP-3)
Time frame: Weeks 0, 26, and 52
Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52
Time frame: Week 0 to Week 52
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Weeks 0, 26, and 52
Number of Participants With Adverse Events (AEs)
Time frame: Week 0 to Week 52

Results and safety

Results posted to the registry on 11 Dec 2013, 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	106	65
Non-Adalimumab	114	92

Primary outcome: Disease Activity Score (DAS28)

Time frame: Weeks 0, 26, and 52. Mean (Standard Deviation). Unit: units on a scale

Measure	Adalimumab n = 91	Non-Adalimumab n = 95
Week 0	2.93 (1.05)	2.73 (1.04)
Week 26	2.72 (1.12)	3.17 (1.11)
Week 52	2.70 (1.08)	3.20 (1.24)

Adalimumab vs Non-Adalimumab: p = 0.144, Wilcoxon Rank Sum
Adalimumab vs Non-Adalimumab: p = 0.004, Wilcoxon Rank Sum
Adalimumab vs Non-Adalimumab: p = 0.006, Wilcoxon Rank Sum

Population analysed: All participants with post-baseline DAS28 data, using last-observation-carried forward (LOCF) imputation method.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 0 to Week 52. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adalimumab	5 of 106 (4.7%)	46 of 106 (43.4%)	Not reported
Non-Adalimumab	3 of 114 (2.6%)	36 of 114 (31.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26925252Tanaka Y, Yamanaka H, Ishiguro N, Miyasaka N, Kawana K, Hiramatsu K, Takeuchi T. Adalimumab discontinuation in patients with early rheumatoid arthritis who were initially treated with methotrexate alone or in combination with adalimumab: 1 year outcomes of the HOPEFUL-2 study. RMD Open. 2016 Feb 18;2(1):e000189. doi: 10.1136/rmdopen-2015-000189. eCollection 2016.
Related InfoLink provided by the sponsor.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Recruiting
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Rheumatoid Arthritis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus

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.

Aki Kuroki study director

AbbVie

75 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott) at 75 sites in Japan.

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 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Dec 2013). 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?

Disease Activity Score (DAS28) (time frame: Weeks 0, 26, and 52). 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 NCT01163292, 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 6 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.