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

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 31, 2018

Primary Completion Date

May 31, 2019

Study Completion Date

September 30, 2019

Conditions
Rheumatoid Arthritis
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 (1)

All Listed Sponsors
collaborator

Techtrials Pesquisa e Tecnologia Ltda

UNKNOWN

collaborator

Pharmagenix

UNKNOWN

lead

Bird Rock Bio, Inc.

INDUSTRY

NCT02795299 - Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFα Antagonist Failed in Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter