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Rheumatoid ArthritisPhase 4NCT01554917

A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

A Phase 4 study testing Iguratimod in people with Rheumatoid Arthritis, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.

Completed

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

Official record
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Trial summary

This study is intended to evaluate the safety and efficacy of Iguratimod in patients with active Rheumatoid Arthritis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Iguratimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,759 participants
Where
1 siteChina
Study dates
May 2012to Aug 2015
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

  • Subjects with a diagnosis of RA
  • Subjects who have active RA at the time of screening
  • Subjects who haven't used any antirheumatic drugs or have used antirheumatic drugs for more than 3 months at the time of screening
  • Written informed consent

Who cannot join

  • Subjects with serious cardiovascular, renal, hematologic or endocrine diseases
  • Pregnant or lactating women
  • ALT>1.5×ULN, AST>1.5×ULN, Cr>135umol/L
  • WBC<4×109/L，HGB<85g/L，PLT<100×109/L
  • Subjects with uncontrolled infection
  • Patients with active gastrointestinal diseases (such as gastric ulcer, etc.)
Show all 10Show fewer
  • Allergic to any of the study drugs
  • History of alcoholism
  • Subjects receiving live vaccines within 3 months prior to study entry
  • Subjects participating in other clinical study within 3 months prior to study entry

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University People's Hospital

    Beijing

Other trials in China

About this study

Official title: A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)

This study is intended to evaluate the safety and efficacy of Iguratimod in patients with active Rheumatoid Arthritis.

Read the detailed description

This is a multi-center, open, single arm study.

Being tested
Iguratimod
Keywords
Rheumatoid Arthritis, Iguratimod
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • IguratimodDrug

    taken orally, 2 tablets/day (bid)

Study groups in NCT01554917
Study groupRoleWhat they receive
IguratimodExperimentalNot described
Receives: Drug: Iguratimod

What is being measured

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

  1. Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20)

    Measured: week 24

  2. Incidence of adverse events

    Measured: up to 28 weeks

Secondary outcomes (4)

  1. Percentage of patients meeting the American College of Rheumatology 50% response criteria (ACR50)

    Measured: week 24

  2. Percentage of patients meeting the American College of Rheumatology 70% response criteria (ACR70)

    Measured: week 24

  3. Change from baseline in Disease Activity Score 28 (DAS28)

    Measured: week 24

  4. Change from baseline in Health Assessment Questionnaire (HAQ)

    Measured: week 24

Timeline

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

  1. First posted15 Mar 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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
1,759 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01554917
Sponsor's protocol ID
SIM-109
Status last verified
Oct 2020
First submitted
12 Mar 2012
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Mu R, Li C, Li X, Ke Y, Zhao L, Chen L, Wu R, Wu Z, Zuo X, Xie Y, Chen J, Wei W, Liu Y, Li Z, Dai L, Sun L, Liu X, Li Z. Effectiveness and safety of iguratimod treatment in patients with active rheumatoid arthritis in Chinese: A nationwide, prospective real-world study. Lancet Reg Health West Pac. 2021 Mar 22;10:100128. doi: 10.1016/j.lanwpc.2021.100128. eCollection 2021 May.

    PubMed 34327344

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Iguratimod in people with Rheumatoid Arthritis, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.

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 4 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 14 Oct 2020. 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 China. 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?

Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20) (time frame: week 24). The study lists 2 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 NCT01554917, 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 14 Oct 2020.

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