Arthritis, RheumatoidPhase 4OPTIWITNCT02770794
Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis
A Phase 4 study testing Infliximab in people with Arthritis, Rheumatoid, run by Chiba University at 1 site in Japan.
Trial summary
This multicenter prospective clinical trial investigates the accuracy of ultrasound to predict relapse after discontinuation of infliximab and the efficacy/safety of readministration of infliximab in patients with rheumatoid arthritis in a low disease activity state. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Infliximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteJapan
- Study dates
- 1 Apr 2016to 14 Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- RA patients who fulfill 2010 ACR/EULAR Classification Criteria
- Patients who have been treated with infliximab (Remicade) for 26 weeks or longer
- DAS28 (CRP) < 3.2 at screening
- Patients who give written informed consent after receiving sufficient information -
Who cannot join
- Receiving prednisolone > 10 mg/day
- Receiving biological or molecular-target anti-rheumatic drug
- Alteration of the dose of corticosteroid or anti-rheumatic drug within 8 weeks prior to screening visit
- Alteration of the dose of non-steroid anti-inflammatory drug within 4 weeks prior to screening visit
- History of infusion reaction to infliximab
- Current infection which requires treatment
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- Current or previous demyelinating disorder
- Current congestive heart failure which requires treatment
- Breast-feeding or pregnant/possibly pregnant woman, or woman who does not agree to prevent conception during and 6 months after study period
- Patients whom investigator or co-investigator consider inappropriate for other reasons -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Prospective Trial to Investigate Accuracy of Ultrasound to Predict Relapse After Discontinuation of Infliximab and Efficacy/Safety of Readministration of Infliximab in Patients With Rheumatoid Arthritis in Low Disease Activity
This multicenter prospective clinical trial investigates the accuracy of ultrasound to predict relapse after discontinuation of infliximab and the efficacy/safety of readministration of infliximab in patients with rheumatoid arthritis in a low disease activity state.
Read the detailed description
The objective of this multicenter prospective clinical trial is to determine whether ultrasound predicts relapse after discontinuation of infliximab more accurately than does clinical index and to investigate the efficacy and safety of restarting infliximab after relapse in patients with rheumatoid arthritis in remission or low disease activity on infliximab treatment. Infliximab is discontinued in all enrolled patients. Patients are followed up for 48 weeks for monitoring relapse. If relapse occurs, patients receive readministration of infliximab and are further followed up for 24 weeks to determine the efficacy and safety of infliximab readministration. Primary endpoint is the difference in area under curve (AUC) of receiver operator characteristics (ROC) analysis between total power Doppler score and Disease Activity Score (DAS) 28 at baseline to predict relapse within 48 weeks after discontinuation of infliximab.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Infliximab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Discontinue infliximab; receive Infliximab when relapse
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Discontinue infliximab; Receive infliximab when relapse Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Receiver Operator Characteristic (ROC) curve for total power Doppler score to predict relapse
Area under the ROC curve for total power Doppler score at baseline to predict relapse within 48 weeks after discontinuation of infliximab
Measured: 48 week
Secondary outcomes (6)
Area under the ROC curve for total gray-scale score to predict relapse
Area under the ROC curve for total gray-scale score at baseline to predict relapse within 48 weeks after discontinuation of infliximab
Measured: 48 week
Change in van der Heijde modified Sharp score
Change in van der Heijde modified Sharp score at 48 week
Measured: 48 week
Change in Health Assessment Questionnaire-Disability Index
Change in Health Assessment Questionnaire-Disability Index at 48 week
Measured: 48 week
Change in EuroQoL 5 dimensions-5L
Change in EuroQoL 5 dimensions-5L at 48 week
Measured: 48 week
EULAR response criteria based on DAS28 after readministration of infliximab
EULAR response criteria based on DAS28 at 12 week after relapse and readministration of infliximab
Measured: 12 week after relapse
Number of adverse events as assessed by CTCAE v4.0
Number of adverse events as assessed by CTCAE v4.0 through study completion, an average of 60 weeks
Measured: Through study completion, an average of 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start1 Apr 2016
- Primary completion14 Aug 2020
- Study completion14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiba University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kei Ikeda, Chiba University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770794
- Sponsor's protocol ID
- 137
- Acronym
- OPTIWIT
- Status last verified
- Jan 2021
- First submitted
- 11 May 2016
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Iwamoto T, Ikeda K, Hosokawa J, Yamagata M, Tanaka S, Norimoto A, Sanayama Y, Nakagomi D, Takahashi K, Hirose K, Sugiyama T, Sueishi M, Nakajima H. Prediction of relapse after discontinuation of biologic agents by ultrasonographic assessment in patients with rheumatoid arthritis in clinical remission: high predictive values of total gray-scale and power Doppler scores that represent residual synovial inflammation before discontinuation. Arthritis Care Res (Hoboken). 2014 Oct;66(10):1576-81. doi: 10.1002/acr.22303.
PubMed 24515410Tanaka Y, Takeuchi T, Mimori T, Saito K, Nawata M, Kameda H, Nojima T, Miyasaka N, Koike T; RRR study investigators. Discontinuation of infliximab after attaining low disease activity in patients with rheumatoid arthritis: RRR (remission induction by Remicade in RA) study. Ann Rheum Dis. 2010 Jul;69(7):1286-91. doi: 10.1136/ard.2009.121491. Epub 2010 Apr 1.
PubMed 20360136
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Trial to Investigate Accuracy of Ultrasound to Predict Relapse After Discontinuation of Infliximab and Efficacy/Safety of Readministration of Infliximab in Patients With Rheumatoid Arthritis in Low Disease Activity
- ClinicalTrials.gov ID
- NCT02770794
- Acronym / sponsor ID
- OPTIWIT / 137
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Chiba UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter prospective clinical trial investigates the accuracy of ultrasound to predict relapse after discontinuation of infliximab and the efficacy/safety of readministration of infliximab in patients with rheumatoid arthritis in a low disease activity state.
Detailed description
The objective of this multicenter prospective clinical trial is to determine whether ultrasound predicts relapse after discontinuation of infliximab more accurately than does clinical index and to investigate the efficacy and safety of restarting infliximab after relapse in patients with rheumatoid arthritis in remission or low disease activity on infliximab treatment. Infliximab is discontinued in all enrolled patients. Patients are followed up for 48 weeks for monitoring relapse. If relapse occurs, patients receive readministration of infliximab and are further followed up for 24 weeks to determine the efficacy and safety of infliximab readministration. Primary endpoint is the difference in area under curve (AUC) of receiver operator characteristics (ROC) analysis between total power Doppler score and Disease Activity Score (DAS) 28 at baseline to predict relapse within 48 weeks after discontinuation of infliximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Drug: InfliximabDiscontinue infliximab; Receive infliximab when relapse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- RA patients who fulfill 2010 ACR/EULAR Classification Criteria
- Patients who have been treated with infliximab (Remicade) for 26 weeks or longer
- DAS28 (CRP) < 3.2 at screening
- Patients who give written informed consent after receiving sufficient information -
Key exclusion criteria (10 listed)
- Receiving prednisolone > 10 mg/day
- Receiving biological or molecular-target anti-rheumatic drug
- Alteration of the dose of corticosteroid or anti-rheumatic drug within 8 weeks prior to screening visit
- Alteration of the dose of non-steroid anti-inflammatory drug within 4 weeks prior to screening visit
- History of infusion reaction to infliximab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabDiscontinue infliximab; receive Infliximab when relapse | Drug | All patients |
Primary outcome
Area under the Receiver Operator Characteristic (ROC) curve for total power Doppler score to predict relapse
Time frame: 48 week
Area under the ROC curve for total power Doppler score at baseline to predict relapse within 48 weeks after discontinuation of infliximab
6 secondary outcomes
Area under the ROC curve for total gray-scale score to predict relapse
Time frame: 48 week
Change in van der Heijde modified Sharp score
Time frame: 48 week
Change in Health Assessment Questionnaire-Disability Index
Time frame: 48 week
Change in EuroQoL 5 dimensions-5L
Time frame: 48 week
EULAR response criteria based on DAS28 after readministration of infliximab
Time frame: 12 week after relapse
Number of adverse events as assessed by CTCAE v4.0
Time frame: Through study completion, an average of 60 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Background: PubMed 24515410Iwamoto T, Ikeda K, Hosokawa J, Yamagata M, Tanaka S, Norimoto A, Sanayama Y, Nakagomi D, Takahashi K, Hirose K, Sugiyama T, Sueishi M, Nakajima H. Prediction of relapse after discontinuation of biologic agents by ultrasonographic assessment in patients with rheumatoid arthritis in clinical remission: high predictive values of total gray-scale and power Doppler scores that represent residual synovial inflammation before discontinuation. Arthritis Care Res (Hoboken). 2014 Oct;66(10):1576-81. doi: 10.1002/acr.22303.
- Background: PubMed 20360136Tanaka Y, Takeuchi T, Mimori T, Saito K, Nawata M, Kameda H, Nojima T, Miyasaka N, Koike T; RRR study investigators. Discontinuation of infliximab after attaining low disease activity in patients with rheumatoid arthritis: RRR (remission induction by Remicade in RA) study. Ann Rheum Dis. 2010 Jul;69(7):1286-91. doi: 10.1136/ard.2009.121491. Epub 2010 Apr 1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab in people with Arthritis, Rheumatoid, run by Chiba University at 1 site 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 5 inclusion and 10 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 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the Receiver Operator Characteristic (ROC) curve for total power Doppler score to predict relapse (time frame: 48 week). 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 NCT02770794, which also lists 2 linked publications.
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 20 Jan 2021.