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Label indication HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active r heumatoid a rthritis . FDA label
Also known as ABT-D2E7, Humira
OLE BSA Adalimumab+ MTX · 1 trial · 1 indication
The primary efficacy endpoint was the number of adalimumab-treated subjects in the non-MTX stratum with disease flare during the Double-Blind Phase compared with the number of placebo-treated subjects in the non-MTX stratum with disease flare during the double-blind phase. Subjects met the criteria for disease flare if they had 1) \>= 30% worsening in at least 3 of the 6 Juvenile Rheumatoid Arthritis (JRA) core set criteria and a minimum of 2 active joints, and 2) \>= 30% improvement in not more than 1 of the 6 JRA core set criteria.
| Arm | Type | Description |
|---|---|---|
| Double-Blind Adalimumab + MTX | EXPERIMENTAL | Subjects who were inadequate responders to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase received adalimumab plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening. |
| Double-Blind Placebo + MTX | PLACEBO_COMPARATOR | Subjects who were inadequate responders to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase received placebo plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening. |
| Double-Blind Adalimumab | EXPERIMENTAL | Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab, but no concomitant MTX treatment, during the Double-Blind Phase. |
| Double-Blind Placebo | PLACEBO_COMPARATOR | Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo, but no concomitant MTX treatment, during the Double-Blind Phase. |
| OLE BSA Adalimumab + MTX | EXPERIMENTAL | All subjects received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow), concomitantly with MTX treatment, during the Open-Label Extension (OLE) BSA Phase of the study. |
| OLE BSA Adalimumab | EXPERIMENTAL | All subjects received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow), but not MTX treatment, during the Open-Label Extension (OLE) BSA Phase of the study. |
| OLE FD Adalimumab + MTX | EXPERIMENTAL | Subjects received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow. |
| OLE FD Adalimumab | EXPERIMENTAL | Subjects received placebo without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow. |
| Name | Type | Description |
|---|---|---|
| Double-Blind Adalimumab/Placebo + MTX | BIOLOGICAL | Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) concomitantly with MTX treatment for 32 weeks during the Double-Blind phase. Total body dose of adalimumab was not to exceed 40 mg. |
| Double-Blind Adalimumab/Placebo | BIOLOGICAL | Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) without MTX treatment for 32 weeks during the Double-Blind Phase. Total body dose of adalimumab was not to exceed 40 mg. |
| OLE BSA Adalimumab +/- MTX | DRUG | Comparison of subcutaneous injection of 24 mg adalimumab per square meter of body surface area (BSA) every other week (eow) either with or without concomitant MTX treatment for a minimum of 44 weeks (up to a maximum of 136 weeks) during the Open-Label Extension BSA Phase. |
| OLE FD Adalimumab +/- MTX | DRUG | Comparison of adalimumab administered subcutaneously every other week (eow) either with or without concomitant MTX treatment for up to 224 weeks during the Open-Label Extension Fixed Dose (FD) Phase. |
Inclusion Criteria: * Subjects must have a diagnosis of polyarticular juvenile idiopathic arthritis (JIA) age 4 to 17 by the American College of Rheumatology (ACR) criteria. Disease onset may have been systemic, polyarticular, or pauciarticular. If the disease was systemic onset, then the subjects ...
OLE BSA Adalimumab+ MTX is an open-label extension study of adalimumab, a human anti-TNF monoclonal antibody, given with or without methotrexate in children with polyarticular juvenile idiopathic arthritis. It is a Phase 3 clinical trial, not a separate drug product.
It was studied in children with polyarticular juvenile idiopathic arthritis, a form of chronic inflammatory joint disease. The trial enrolled 171 participants aged 4 years and older across the United States, Belgium, Czechia, France, Germany, Italy, Slovakia and Spain.
Adalimumab is a human monoclonal antibody that targets tumor necrosis factor, or TNF. By binding TNF, it is designed to reduce the inflammatory signaling involved in juvenile idiopathic arthritis. The OLE BSA study evaluated this antibody given with or without methotrexate.
Abbott Laboratories, ticker ABT, is the developer listed for the OLE BSA Adalimumab+ MTX study. The trial was conducted at sites in the United States and several European countries including Belgium, Czechia, France, Germany, Italy, Slovakia and Spain.
OLE BSA Adalimumab+ MTX is a Phase 3 study. It is a completed, randomized, double-blind, placebo-controlled trial that enrolled 171 children with polyarticular juvenile idiopathic arthritis. No active trials of this study are ongoing.
The study is registered as NCT00048542, titled Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA). It is a completed Phase 3 trial with 171 enrolled participants, open to all sexes and children aged 4 years and older.