Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Golimumab · 1 trial · 1 indication
The ACR20 was defined as greater than or equal to (\>=) 20 percent (%) improvement, in: swollen joint count (SJC) and tender joint count (TJC) and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity (MDGA); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-reactive protein (CRP). If CRP was missing and Erythrocyte sedimentation rate (ESR) was present then ESR was to be used.
The ACR50 was defined as \>=50% improvement, in: SJC and TJC and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.
The ACR70 was defined as \>=70% improvement, in: SJC and TJC and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.
The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the visual analogue scale (VAS) of 0 (= best), 100 (= worst) plus levels of CRP (milligram/Liter \[mg/L\]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (\<) 3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Participants with score less than 2.6 were analysed. The percentage of participants were calculated by logistic regression model method.
The HAQ-DI: 20-item scale assessing participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arising, eating, hygiene, walking, reaching, grip, and errands/chores over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty. Participants with change from baseline more than or equal to (\>=) 0.25 were reported. The percentage of participants were calculated by logistic regression model method.
| Arm | Type | Description |
|---|---|---|
| Golimumab 50 mg alternating with Placebo | EXPERIMENTAL | Participants received alternating doses of golimumab 50 milligram (mg) (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. |
| Mavrilimumab 100 mg | EXPERIMENTAL | Participants received Mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. |
| Name | Type | Description |
|---|---|---|
| Golimumab 50 mg | BIOLOGICAL | Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. |
| Mavrilimumab 100 mg | BIOLOGICAL | Participants received Mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. |
Inclusion Criteria: * Age 18 through 80 years * Written consent * Diagnosis of adult onset Rheumatoid Arthritis (RA) as defined by the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) classification criteria * Moderately active disease as defined by disease activ...
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Golimumab is a monoclonal antibody being studied for the treatment of Rheumatoid Arthritis. It is currently in Phase 2 clinical development and is being developed by AstraZeneca PLC. The drug is intended for patients with this autoimmune condition, though it remains investigational and is not yet approved.
Golimumab is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Rheumatoid Arthritis.
Golimumab is currently in Phase 2 clinical development. It has completed one Phase 2 trial with 215 participants, which was a randomized, double-blind, controlled study. The drug is still investigational and has not been approved for any use.
Golimumab has been studied in a completed Phase 2 clinical trial registered as NCT01715896. This trial, titled 'A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis,' enrolled 215 participants across multiple countries including Argentina, Colombia, France, Greece, and the United Kingdom.
Golimumab is also known as Mavrilimumab. The clinical trial NCT01715896, which studied the drug in Rheumatoid Arthritis, used the name Mavrilimumab in its title. Both names refer to the same investigational monoclonal antibody being developed by AstraZeneca PLC.