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Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Iguratimod

Methotrexate

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Iguratimod, Methotrexate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Iguratimod monotherapy

Iguratimod and MTX combination

MTX monotherapy

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients with ACR 20 response

Change from baseline in modified Total Sharp Score (mTSS)

Secondary Outcome Measures

Change from baseline in mTSS

Percentage of patients achieving radiographic non-progression

Percentage of patients with ACR 20 response

Percentage of patients with ACR 50 response

Percentage of patients with ACR 70 response

Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3

Change from baseline in Health Assessment Questionnaire (HAQ)

Incidence of adverse events

Full Information

NCT ID

NCT01548001

First Posted

March 5, 2012

Last Updated

February 22, 2016

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01548001

Brief Title

Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Official Title

A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod Alone or Iguratimod in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

November 2016 (Anticipated)

Study Completion Date

January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Iguratimod, Methotrexate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

910 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Iguratimod monotherapy

Arm Type

Experimental

Arm Title

Iguratimod and MTX combination

Arm Type

Experimental

Arm Title

MTX monotherapy

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Iguratimod

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of patients with ACR 20 response

Time Frame

week 52

Title

Change from baseline in modified Total Sharp Score (mTSS)

Time Frame

week 52

Secondary Outcome Measure Information:

Title

Change from baseline in mTSS

Time Frame

week 24

Title

Percentage of patients achieving radiographic non-progression

Time Frame

week 24, week 52

Title

Percentage of patients with ACR 20 response

Time Frame

week 12, week 24, week 40

Title

Percentage of patients with ACR 50 response

Time Frame

week 12, week 24, week 40, week 52

Title

Percentage of patients with ACR 70 response

Time Frame

week 12, week 24, week 40, week 52

Title

Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3

Time Frame

week 12, week 24, week 40, week 52

Title

Change from baseline in Health Assessment Questionnaire (HAQ)

Time Frame

week 12, week 24, week 40, week 52

Title

Incidence of adverse events

Time Frame

up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chunde Bao, MD

Organizational Affiliation

RenJi Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis

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