NCT01548001

Brief Summary

This study is intended to evaluate the efficacy and safety of Iguratimod alone or Iguratimod in combination with Methotrexate (MTX) versus Methotrexate alone in patients with Rheumatoid Arthritis (RA).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
910

participants targeted

Target at P75+ for phase_4 rheumatoid-arthritis

Timeline
Completed

Started May 2012

Longer than P75 for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

4.5 years

First QC Date

March 5, 2012

Last Update Submit

February 22, 2016

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisIguratimodMethotrexate

Outcome Measures

Primary Outcomes (2)

  • Percentage of patients with ACR 20 response

    week 52

  • Change from baseline in modified Total Sharp Score (mTSS)

    week 52

Secondary Outcomes (8)

  • Change from baseline in mTSS

    week 24

  • Percentage of patients achieving radiographic non-progression

    week 24, week 52

  • Percentage of patients with ACR 20 response

    week 12, week 24, week 40

  • Percentage of patients with ACR 50 response

    week 12, week 24, week 40, week 52

  • Percentage of patients with ACR 70 response

    week 12, week 24, week 40, week 52

  • +3 more secondary outcomes

Study Arms (3)

Iguratimod monotherapy

EXPERIMENTAL
Drug: Iguratimod

Iguratimod and MTX combination

EXPERIMENTAL
Drug: IguratimodDrug: Methotrexate

MTX monotherapy

ACTIVE COMPARATOR
Drug: Methotrexate

Interventions

IguratimodDRUG

25 mg/tablet, taken orally, 2 tablets/day (bid)

Iguratimod and MTX combinationIguratimod monotherapy
MethotrexateDRUG

2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)

Iguratimod and MTX combinationMTX monotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987)
  • Rheumatoid Arthritis for 3 months to 2 years from the time of the initial diagnosis
  • Subjects have active RA at the time of screening
  • Subjects are naive to MTX or RA related biologics
  • Written informed consent

You may not qualify if:

  • Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or Tripterygium within 4 weeks prior to study entry
  • Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc.
  • ALT \>1.5×ULN, AST \>1.5×ULN, Cr \>135umol/L
  • WBC\<4×109/L，HGB\<85g/L，PLT\<100×109/L
  • Subjects with serious cardiovascular, renal, hematologic or endocrine diseases
  • Pregnant or lactating women
  • Allergic to any of the study drugs
  • History of alcoholism
  • Subjects with mental illness
  • Subjects receiving live vaccines recently
  • Subjects participating in other clinical study within 3 months prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Related Publications (1)

  • Du F, Dai Q, Teng J, Lu L, Ye S, Ye P, Lin Z, Ding H, Dai M, Bao C; SMILE Group. The SMILE study: Study of long-term methotrexate and iguratimod combination therapy in early rheumatoid arthritis. Chin Med J (Engl). 2025 Jul 20;138(14):1705-1713. doi: 10.1097/CM9.0000000000003200. Epub 2024 Jul 26.

    PMID: 39056160DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

iguratimodMethotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Chunde Bao, MD

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 8, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

CN(1)