How many clinical trials are studying Golimumab?

3 recruiting trials in our tracked data involve Golimumab.

What conditions is Golimumab being studied for?

In our tracked recruiting trials, Golimumab is being studied in trials for Psoriasis, Rheumatoid Arthritis, Lupus.

Golimumab: clinical trials recruiting now

Q: Is Golimumab FDA-approved?

Yes. According to the FDA drug label available through openFDA, Golimumab is an FDA-approved drug. Its FDA label carries a boxed warning.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Golimumab appears in the FDA drug-label database. Marketed as SIMPONI ARIA.
Drug class: Tumor Necrosis Factor Blocker (FDA established pharmacologic class)
Mechanism of action: Tumor Necrosis Factor Receptor Blocking Activity (as stated on the FDA label)
Boxed warning: The FDA label for Golimumab carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate ( 1.1 ) Active Psoriatic Arthritis (PsA) in patients 2 years of age and older ( 1.2 ) Adult patients with active Ankylosing Spondylitis (AS) ( 1.3 ) Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older ( 1.4 ) 1.1 Rheumatoid Arthritis (RA) SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. 1.2 Psoriatic Arthritis (PsA) SIMPONI ARIA is indicated for the treatment of active psoriatic arthritis in patients 2 years of age and older. 1.3 Ankylosing Spondylitis (AS) SIMPONI ARIA is indicated for the treatment of adult patients with active ankylosing spondylitis. 1.4 Polyarticular Juvenile Idiopathic Arthritis (pJIA) SIMPONI ARIA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.

FDA label via openFDA

Phase breakdown

Phase 2 1 Phase 3 2

Conditions being studied

Condition	Trials
Psoriasis	2
Rheumatoid Arthritis	2
Lupus	1
Psoriatic Arthritis	1
Rheumatic Disease	1

Recruiting trials involving Golimumab

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
NCT05669833 · Phase: Phase 3 · Ages: 18 Years to 80 Years · Sex: All (male and female) · 14 locations
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
NCT07138898 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 2 locations
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
NCT03414502 · Phase: Phase 3 · Ages: 19 Years and older · Sex: All (male and female) · 1 location

Common questions

Is Golimumab FDA-approved?

Yes, marketed as SIMPONI ARIA. Its FDA label carries a boxed warning.

How many recruiting trials involve Golimumab?

3 recruiting trials across 5 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.