NCT00335985

Brief Summary

This randomized, double-blind, placebo-controlled trial will carry out to assess the efficacy of GB-0998 in the treatment of the steroid-resistant polymyositis and dermatomyositis based on the changes in manual muscle strength (MMT) scores as primary endpoint, and in addition, to assess the safety of GB-0998.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 5, 2014

Status Verified

February 1, 2012

Enrollment Period

2.8 years

First QC Date

June 8, 2006

Last Update Submit

November 3, 2014

Conditions

PolymyositisDermatomyositis

Keywords

polymyositis, dermatomyositisHigh-dose intravenous immunoglobulinVenoglobulin-IHSteroid-resistant polymyositis(PM) and dermatomyositis(DM)

Outcome Measures

Primary Outcomes (1)

  • Changes in manual muscle strength (MMT) scores

    8 weeks

Secondary Outcomes (2)

  • Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL)

    8 weeks

  • Adverse events and laboratory tests

    8 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: GB-0998

2

PLACEBO COMPARATOR
Drug: Placebo of GB-0998

Interventions

GB-0998DRUG

8 mL (400 mg of GB-0998)/kg per day is intravenously administered for five successive days

Also known as: High-dose intravenous immunoglobulin, Venoglobulin-IH
1
Placebo of GB-0998DRUG

8 mL/kg per day is intravenously administered for five successive days

2

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have been defined as "definite" based on the criteria of Bohan and Peter for polymyositis and dermatomyositis.
  • Patients who are defined as steroid-resistant ones based on the changes of scores on manual muscle testing (MMT) and serum levels of creatine kinase (CK) during observation period before administration of drug.

You may not qualify if:

  • Patients with malignant tumors.
  • Patients with acute interstitial pneumonia, including acute exacerbation of chronic.
  • Patients with severe muscular atrophy for a long period.
  • Patients with severe infectious disease.
  • Patients who have the anamnesis of shock or hypersensitivity to this drug.
  • Patients with severe hepatic disorder or severe renal disorder.
  • Patients who have the anamnesis of cerebral infarction or ischemic heart disease, or who having symptom of these diseases.
  • Patients who have been diagnosed as IgA deficiency in their past history.
  • Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant.
  • Patients who were administered immunoglobulin dosage within 6 weeks before consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokyo Medical and Dental University

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

MeSH Terms

Conditions

PolymyositisDermatomyositis

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

MyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Nobuyuki Miyasaka, Professor

    Tokyo Medical and Dental University

    STUDY CHAIR

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

June 8, 2006

First Posted

June 12, 2006

Study Start

June 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 5, 2014

Record last verified: 2012-02

Locations

JP(1)