Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Golimumab · 12 trials · 9 indications
Percentage of participants with clinical remission at Week 6 as assessed by the Mayo score was reported. Clinical remission was defined as a Mayo score of less than or equal to (\<=) 2 point, with no individual sub-score greater than (\>) 1. The Mayo score was sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease.
Serum golimumab trough concentration at Week 28 was reported.
AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).
The ACR 20 response is defined as greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=20% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter \[cm\] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (\>=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI \[0=no functional impairment to 10= maximal impairment\]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale \[VAS\]), and an absence of deterioration (defined as \>=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.
Clinical response was defined as a decrease from Induction-Week 0 in the Mayo score by greater than or equal to (\>=) 30 percent and \>=3 points, with a decrease in the rectal bleeding subscore of \>= 1 or a rectal bleeding subscore of 0 or 1. The Mayo score is the primary tool for assessing ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, findings of endoscopy, and physician's global assessment) which range from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.
Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (\>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and \>=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters \[cm\]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.
Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (\>=) 30 percent and \>= 3, with either decrease from induction baseline in rectal bleeding subscore of \>= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.
MMTT-Stimulated 4-Hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 4-hour period divided by the duration after a mixed-meal tolerance test.
The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of a subset of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict mucosal healing at Week 6. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting mucosal healing than "flipping a coin". Areas above 0.5 represent increasing accuracy.
Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Sample will be collected prior to the administration of study medication.
| Arm | Type | Description |
|---|---|---|
| Group 1: Golimumab | EXPERIMENTAL | Participants will receive subcutaneous (SC) golimumab through Week 50. Doses will be based on body surface area. Following the Week 54 evaluations (end of main pivotal study) participants who are benefiting from golimumab at the discretion of the investigator may continue to receive SC golimumab in an extension period until end of study. |
| Group 2: Infliximab | EXPERIMENTAL | Participants will receive infliximab intravenous (IV) through Week 46. Doses will be based on body weight. After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their physician. |
| Golimumab + Methotrexate | EXPERIMENTAL | Participants will receive 80 milligram per meter square (mg/m\^2) as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks thereafter up to Week 244, along with commercial methotrexate (MTX) weekly through Week 28 at the same Body Surface Area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square (m\^2), or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at the time of study entry. At Week 252, participants who meet the criteria for the optional Extended Treatment Period (ETP) may continue treatment with golimumab 80 mg/m\^2 every 8 weeks after completion of the Week 252 assessments. |
| Treatment Group 1: Placebo | PLACEBO_COMPARATOR | Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20. At Week 24, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and thereafter every 8 weeks up to Week 52. |
| Treatment Group 2: Golimumab | EXPERIMENTAL | Participants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants will receive a placebo infusion to maintain the blind. |
| Treatment Group 1: Placebo then Golimumab | EXPERIMENTAL | Participants will receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Weeks 16, 20 and thereafter every 8 weeks up to Week 52. |
| Golimumab | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX | EXPERIMENTAL | All enrolled and dosed participants receive golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 0 to Week 12. |
| Double blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX | EXPERIMENTAL | Participants, who do not achieve Disease Activity Score in 28 joints (DAS28) good response at Week 16, will be randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44. |
| DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX | EXPERIMENTAL | Participants, who do not achieve DAS28 good response at Week 16, will be randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48. |
| OL Group 1: Golimumab 50 mg SC + MTX | EXPERIMENTAL | Participants, who achieve DAS28 good response at Week 16, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48. |
| OL Study Extension Group: Golimumab 50 mg SC + MTX | EXPERIMENTAL | Participants who complete the main study (Week 0 to Week 52), do not meet lack of efficacy criteria, and participate in the OL study extension, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72. |
| Golimumab induction responders (GLM-I-Rsp)-Placebo Maintenance | PLACEBO_COMPARATOR | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. |
| GLM-I-Rsp-Golimumab 50 mg Maintenance | EXPERIMENTAL | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks through Week 52. |
| GLM-I-Rsp-Golimumab 100 mg Maintenance | EXPERIMENTAL | Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injections every 4 weeks through Week 52. |
| Placebo induction responders (PBO-I-Rsp)-Placebo Maintenance | PLACEBO_COMPARATOR | Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. |
| PBO-I-nonRsp-Golimumab 100 mg Maintenance | EXPERIMENTAL | Participants not in clinical response to placebo at Week 6 induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. |
| GLM-I-nonRsp-Golimumab 100 mg Maintenance | EXPERIMENTAL | Participants not in clinical response to golimumab at Week 6 of induction study and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. |
| Group 2: Placebo | PLACEBO_COMPARATOR | Participants will receive a matching placebo to golimumab. |
| Golimumab 100 mg -> 50 mg | EXPERIMENTAL | Golimumab 100 milligram (mg) subcutaneous injection administered at Week 0 and dose is decreased to 50 mg at Week 2. |
| Golimumab 200 mg -> 100 mg | EXPERIMENTAL | Golimumab 200 mg subcutaneous injection administered at Week 0 and dose is decreased to 100 mg at Week 2. |
| Golimumab 400 mg -> 200 mg | EXPERIMENTAL | Golimumab 400 mg subcutaneous injection administered at Week 0 and dose is decreased to 200 mg at Week 2. |
| Name | Type | Description |
|---|---|---|
| Golimumab | DRUG | Participants receive subcutaneous (SC) golimumab through Week 50, where doses will be based on body surface area. After the Week 54 evaluations, at the discretion of investigator, participants benefiting from continued SC golimumab will continue to receive SC golimumab in the extension until end of study. |
| Infliximab | DRUG | Participants will receive infliximab intravenous (IV) through Week 46. Doses will be based on body weight. After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their physician. |
| Methotrexate | DRUG | Methotrexate BSA-based dose (10 to 30 mg/m\^2 per week for participants with BSA \<1.67 m\^2, or minimum of 15 mg/week for participants with BSA \>=1.67 m\^2) weekly at least through Week 28. |
| Placebo | DRUG | Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20 in treatment Group 1 and intravenous infusions of placebo at Week 24 to maintain the blind in treatment Group 2. |
| Golimumab 50 mg SC | DRUG | Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks. |
| Golimumab 2 mg/kg IV | DRUG | Golimumab 2 milligram per kilogram (mg/kg) intravenous infusion every 8 weeks. |
| Methotrexate (MTX) | DRUG | Participants will continue taking their current Methotrexate (MTX) treatment regimen. |
| Placebo SC | DRUG | Placebo matched to golimumab SC injection every 4 weeks. |
| Placebo IV | DRUG | Placebo matched to golimumab intravenous infusion every 8 weeks. |
| Golimumab 50 mg | BIOLOGICAL | Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). |
| Golimumab 100 mg | BIOLOGICAL | Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response. |
| Golimumab 200 mg | BIOLOGICAL | Participants receiving golimumab 100 mg initially who on loss of clinical response receive golimumab 200 mg administered every 4 weeks through Week 52. |
| Golimumab 400 mg | BIOLOGICAL | Golimumab 400 mg subcutaneous injection administered at Week 0 for Golimumab 400 mg -\> 200 mg arm group. |
Inclusion Criteria: * Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate or azathioprine OR must either ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| XBiotech, Inc. | XBIT | 1 | PHASE2 | vilamakitug |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Upadacitinib |
| Novartis AG Sponsored ADR | NVS | 1 | - | Secukinumab |
| Pfizer Inc. | PFE | 1 | - | Tofacitinib |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Golimumab is a biologic antibody being studied for several immune-related conditions, including psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, ulcerative colitis, and pre-symptomatic type 1 diabetes. It is also under investigation for use in adults with arthritis and related inflammatory disorders.
Golimumab is a monoclonal antibody, indicated by its -mab suffix, that targets tumor necrosis factor alpha (TNF-alpha), a key driver of inflammation in autoimmune diseases. By binding to TNF-alpha, it is designed to reduce inflammatory activity associated with conditions like psoriatic arthritis and juvenile arthritis.
Golimumab is developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is being investigated for multiple inflammatory and autoimmune indications, with ongoing clinical development led by this pharmaceutical company.
Golimumab is in Phase 3 clinical development for several indications, including psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. It has completed Phase 3 trials in these areas, and it is also being studied in an early-phase trial for pre-symptomatic type 1 diabetes.
Golimumab has been studied in several clinical trials, including NCT02181673 for active psoriatic arthritis, NCT02186873 for active ankylosing spondylitis, and NCT02277444 for juvenile idiopathic arthritis. A separate trial, NCT03298542, evaluated the drug in children and young adults with pre-symptomatic type 1 diabetes.
Yes, Golimumab is also known as SIMPONI, as referenced in the clinical trial NCT03298542, which evaluates SIMPONI (Golimumab) therapy. This alternative name is used in some study titles and medical contexts, helping patients and researchers identify the same drug under different branding.