NCT01248780

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with rheumatoid arthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
264

participants targeted

Target at P25-P50 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

9 active sites

Status
completed

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

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 1, 2013

Completed
Last Updated

September 6, 2013

Status Verified

August 1, 2013

Enrollment Period

1.1 years

First QC Date

November 24, 2010

Results QC Date

October 5, 2012

Last Update Submit

August 12, 2013

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritisinjectiongolimumabsimponi

Outcome Measures

Primary Outcomes (1)

  • American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14

    ACR 20 response is defined as \>= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.

    Week 14

Secondary Outcomes (3)

  • Disease Activity Index Score (DAS 28) Response, Using CRP (C-reactive Protein)

    Week 14

  • American College of Rheumatology 20 Response, Using CRP, at Week 24

    Week 24

  • HAQ (Disability Index of the Health Assessment Questionnaire) Score Change From Baseline

    Baseline to Week 24

Study Arms (2)

Golimumab + methotrexate (MTX)

EXPERIMENTAL

Participants will receive golimumab 50 mg as subcutaneous (SC) (under the skin) injections administered every 4 weeks for up to 48 weeks. In addition, participants will receive a stable dose of MTX.

Drug: GolimumabDrug: Methotrexate (MTX)

Placebo + methotrexate (MTX)

EXPERIMENTAL

Participants will be administered Placebo SC injections at Weeks 0, 4, 8, 12, 16, and Week 20 followed by golimumab 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48. In addition, participants will receive a stable dose of MTX.

Drug: PlaceboDrug: Methotrexate (MTX)

Interventions

GolimumabDRUG

50 mg subcutaneous (SC) injection every 4 weeks for up to 48 weeks

Golimumab + methotrexate (MTX)
PlaceboDRUG

Placebo SC injections at Weeks 0, 4, 8, 12, 16, and Week 20 followed by golimumab 50 mg SC injections at Week 24 and every 4 weeks thereafter up to Week 48.

Placebo + methotrexate (MTX)
Methotrexate (MTX)DRUG

A stable dose of MTX (oral or injectable) will be administered to participants according to the local prescribing guidelines for up to 48 weeks.

Golimumab + methotrexate (MTX)Placebo + methotrexate (MTX)

Eligibility Criteria

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

You may qualify if:

  • \- Diagnosis of rheumatoid arthritis for at least 6 months
  • Be on a stable dose of methotrexate for 4 weeks
  • Have at least 4 swollen and 4 tender joints

You may not qualify if:

  • Prior exposure to biologic anti-TNFalpha agents
  • Inflammatory diseases other than rheumatoid arthritis
  • Treatment with Disease Modifying Anti-rheumatic drug (DMARDs)/systemic immunosuppressives other than methotrexate during the 4 weeks prior to the first administration of study agent
  • History of, or ongoing, chronic or recurrent infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Beijing, China

Location

Unknown Facility

Chengdu, China

Location

Unknown Facility

Hefei, China

Location

Unknown Facility

Jinan, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Suzhou, China

Location

Unknown Facility

Wuhan, China

Location

Unknown Facility

Xi'an, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

golimumabMethotrexate

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

Results Point of Contact

Title
Associate Director, Clinical Research
Organization
Janssen Research & Development
610-500-3369

Study Officials

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
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

November 24, 2010

First Posted

November 25, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2011

Study Completion

July 1, 2012

Last Updated

September 6, 2013

Results First Posted

July 1, 2013

Record last verified: 2013-08

Locations

CN(9)