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Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFα Antagonist Failed in Rheumatoid Arthritis

NCT02795299 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-07-11

No results posted yet for this study

Summary

Phase 2 Study Evaluating Gerilimzumab's Safety/Efficacy for Patients with an Inadequate Response to MTX or a TNFα Antagonist in Rheumatoid Arthritis.

Conditions

Interventions

DRUG

Gerilimzumab

Either Gerilimzumab 5 mg followed by 2 mg, or Gerilimzumab 10 mg followed by 5 mg or Gerilimzumab 20 mg followed by 10 mg are to be administered once every 8 weeks during the treatment period of the study.

DRUG

Methotrexate

Methotrexate (MTX) to be administered once a week every week during the treatment period.

DRUG

Folic Acid

Acid folic (folate) 1mg to be administered once daily during the treatment period.

DRUG

Placebo

10 mM acetate, 9% (w/v) sucrose, and 0.006% (w/v) polysorbate 20 at pH 5.2 ± 0.3

Sponsors & Collaborators

  • Techtrials Pesquisa e Tecnologia Ltda

    collaborator UNKNOWN

  • Pharmagenix

    collaborator UNKNOWN

  • Bird Rock Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Mauro Keiserman · LMK - Serviços Medicos Sociedade Simples, Porto Alegre, Rio Grande do Sul, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2019-05-31
Completion
2019-09-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02795299 on ClinicalTrials.gov