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Also known as GP2017
Adalimumab- GP2017 · 2 trials · 2 indications
Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score \<= 0.5.
Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity (GDA) or general health (GH), values range from 0.96 to 10.0 while higher values mean a higher disease activity. • A DAS28-CRP value \>5.1 corresponds to a high disease activity • A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity • A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity • A DAS28-CRP value \< 2.6 corresponds to remission DAS28-CRP = 0.56 \* sqrt(tender28) + 0.28\* sqrt(swollen28) + 0.36 \* ln(CRP+1) + 0.014 \* GDA or GH + 0.96 where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm
| Arm | Type | Description |
|---|---|---|
| AIN457 150 mg/placebo | EXPERIMENTAL | AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100 |
| AIN457 300 mg | EXPERIMENTAL | AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100 |
| GP2017 40mg | ACTIVE_COMPARATOR | GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102 |
| GP2017 | EXPERIMENTAL | Group 1 will receive treatment with 40mg GP2017 (Adalimumab - GP2017) by subcutaneous injection every other week up to 24 weeks (Study Period 1) at which patients achieving at least a moderate clinical response continue treatment with 40mg GP2017 subcutaneous injection every other week up to 48 weeks (Study Period 2). |
| US Licensed Humira | ACTIVE_COMPARATOR | Group 2 will receive treatment with 40mg Humira® (Adalimumab - US licensed Humira®) by subcutaneous injection every other week up to 24 weeks (Study Period 1) at which patients achieving at least a moderate clinical response will be switched to treatment with 40mg GP2017 subcutaneous injection every other week up to 48 weeks (Study Period 2). |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes |
| GP2017 (adalimumab biosimilar) | BIOLOGICAL | 40 mg in pre-filled syringes was administered subcutaneously |
| AIN457 150 mg | BIOLOGICAL | 150 mg in pre-filled syringes was administered subcutaneously |
| Adalimumab - GP2017 | BIOLOGICAL | Adalimumab - GP2017 |
| Adalimumab - US licensed Humira | BIOLOGICAL | Adalimumab - US licensed Humira |
Inclusion Criteria: * Male or non-pregnant, non-nursing female patients at least 18 years of age * Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic D...
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Adalimumab-GP2017 is an investigational monoclonal antibody developed by Novartis AG as a proposed biosimilar to Humira (adalimumab). It is being studied for the treatment of rheumatoid arthritis. It is a Phase 3 candidate and has been evaluated in a single completed clinical trial.
Adalimumab-GP2017 is being developed for the treatment of rheumatoid arthritis, an inflammatory joint disease. Its clinical program has focused on this immunology indication, and it has been studied in adult patients 18 years and older. It is not approved and remains an investigational therapy.
Adalimumab-GP2017 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the clinical program evaluating this monoclonal antibody candidate as a proposed biosimilar to Humira.
Adalimumab-GP2017 is in Phase 3 development. It is an investigational product and is not approved for commercial use. Its single Phase 3 trial has been completed, and no trials are currently listed as active.
Adalimumab-GP2017 has been studied in one Phase 3 trial, NCT02744755, titled a clinical trial to compare treatment with GP2017 and Humira in patients with rheumatoid arthritis. The trial enrolled 353 patients, was randomized, double-blind, and active-controlled, and it has been completed.
Adalimumab-GP2017 is also written as adalimumab - GP2017. It is a proposed biosimilar candidate referencing Humira (adalimumab), meaning it is designed to be a comparable version of that reference product. It is a distinct investigational asset developed by Novartis, not the originator adalimumab.