Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PLA+ MTX switched to ABA+ MTX, DB · 1 trial · 1 indication
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or C-reactive protein (CRP), and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). A clinically significant response is a decrease in DAS28 score of \>1.2 from baseline.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).
High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): \>3 g/dL decrease from Baseline (BL); Hematocrit: \<0.75 x BL; Erythrocytes: \<0.75 x BL; Platelets (PLT): \<0.67 x LLN/\>1.5 x ULN; Leukocytes: \<0.75 x LLN/ \>1.25 x ULN; neutrophils+bands: \<1.0 x 10\^3 c/uL; lymphocytes: \<0.750 x 10\^3 c/uL/ \>7.50 x 10\^3 c/uL; monocytes: \>2000 mm3; eosinophils: \>0.750 x 10\^3 c/uL;
Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): \>2 x ULN; aspartate aminotransferase (AST): \>3 x ULN; alanine aminotransferase (ALT): \>3 x ULN; G-Glutamyl transferase (GGT): \>2 x ULN; Bilirubin: \>2 x ULN; blood urea nitrogen (BUN): \>2 x BL; creatinine: \>4 x BL
Hemoglobin (HGB): \>3 g/dL decrease from BL; total protein: \< 0.9 x LLN, \>1.1 x ULN; albumin:\<0.9 x LLN
Platelets (PLT): \<0.67 x LLN, \>1.5 x ULN
Hematocrit: \<0.75 x BL
Leukocytes: \<0.75 x LLN, \>1.25 x ULN; neutrophils+bands: \<1.0 x 10\^3 c/uL; eosinophils: \>0.750 x 10\^3 c/uL; basophils: \> 400 mm3; monocytes: \>2000 mm3; lymphocytes: \<0.750 x 10\^3 c/uL, \>7.50 x 10\^3 c/uL.
Erythrocytes: \<0.75 x BL
Sodium (Na): \<0.95 x LLN, \>1.05 x ULN; potassium (K): \<0.9 x LLN, \>1.1 x ULN; chloride (Cl): \<0.9 x LLN, \>1.1 x ULN
Bilirubin: \>2 x ULN; blood urea nitrogen (BUN): \>2 x BL; creatinine: \>4 x BL; calcium (Ca): \<0.8 x LLN, \>1.2 x ULN; phosphorous (P): \<0.75 x LLN, \>1.2 5 x ULN; serum glucose (Glu): \<65 mg/dL, \>220 mg/dL; fasting serum Glu: \<0.8 x LLN, \>1.5 x ULN; uric acid: \>1.5 x ULN;
alanine aminotransferase (ALT): \>3 x ULN; aspartate aminotransferase (AST): \>3 x ULN; G-Glutamyl transferase (GGT): \>2 x ULN; Alkaline phosphatase (ALP): \>2 x ULN
Hemoglobin (HGB): \>3 g/dL decrease from BL; total protein: \< 0.9 x LLN, \>1.1 x ULN; albumin:\<0.9 x LLN
Platelets (PLT): \<0.67 x LLN, \>1.5 x ULN
Hematocrit: \<0.75 x BL
Leukocytes: \<0.75 x LLN, \>1.25 x ULN; neutrophils+bands: \<1.0 x 10\^3 c/uL; eosinophils: \>0.750 x 10\^3 c/uL; basophils: \> 400 mm3; monocytes: \>2000 mm3; lymphocytes: \<0.750 x 10\^3 c/uL, \>7.50 x 10\^3 c/uL.
Erythrocytes: \<0.75 x BL
Sodium (Na): \<0.95 x LLN, \>1.05 x ULN; potassium (K): \<0.9 x LLN, \>1.1 x ULN; chloride (Cl): \<0.9 x LLN, \>1.1 x ULN
Bilirubin: \>2 x ULN; blood urea nitrogen (BUN): \>2 x BL; creatinine: \>4 x BL; calcium (Ca): \<0.8 x LLN, \>1.2 x ULN; phosphorous (P): \<0.75 x LLN, \>1.2 5 x ULN; serum glucose (Glu): \<65 mg/dL, \>220 mg/dL; fasting serum Glu: \<0.8 x LLN, \>1.5 x ULN; uric acid: \>1.5 x ULN;
alanine aminotransferase (ALT): \>3 x ULN; aspartate aminotransferase (AST): \>3 x ULN; G-Glutamyl transferase (GGT): \>2 x ULN; Alkaline phosphatase (ALP): \>2 x ULN
Hemoglobin (HGB): \>3 g/dL decrease from BL; total protein: \< 0.9 x LLN, \>1.1 x ULN; albumin:\<0.9 x LLN
Platelets (PLT): \<0.67 x LLN, \>1.5 x ULN
Hematocrit: \<0.75 x BL
Leukocytes: \<0.75 x LLN, \>1.25 x ULN; neutrophils+bands: \<1.0 x 10\^3 c/uL; eosinophils: \>0.750 x 10\^3 c/uL; basophils: \> 400 mm3; monocytes: \>2000 mm3; lymphocytes: \<0.750 x 10\^3 c/uL, \>7.50 x 10\^3 c/uL.
Erythrocytes: \<0.75 x BL
Sodium (Na): \<0.95 x LLN, \>1.05 x ULN; potassium (K): \<0.9 x LLN, \>1.1 x ULN; chloride (Cl): \<0.9 x LLN, \>1.1 x ULN
Bilirubin: \>2 x ULN; blood urea nitrogen (BUN): \>2 x BL; creatinine: \>4 x BL; calcium (Ca): \<0.8 x LLN, \>1.2 x ULN; phosphorous (P): \<0.75 x LLN, \>1.2 5 x ULN; serum glucose (Glu): \<65 mg/dL, \>220 mg/dL; fasting serum Glu: \<0.8 x LLN, \>1.5 x ULN; uric acid: \>1.5 x ULN;
alanine aminotransferase (ALT): \>3 x ULN; aspartate aminotransferase (AST): \>3 x ULN; G-Glutamyl transferase (GGT): \>2 x ULN; Alkaline phosphatase (ALP): \>2 x ULN
Hemoglobin (HGB): \>3 g/dL decrease from BL; total protein: \< 0.9 x LLN, \>1.1 x ULN; albumin:\<0.9 x LLN
Platelets (PLT): \<0.67 x LLN, \>1.5 x ULN
Hematocrit: \<0.75 x BL
Leukocytes: \<0.75 x LLN, \>1.25 x ULN; neutrophils+bands: \<1.0 x 10\^3 c/uL; eosinophils: \>0.750 x 10\^3 c/uL; basophils: \> 400 mm3; monocytes: \>2000 mm3; lymphocytes: \<0.750 x 10\^3 c/uL, \>7.50 x 10\^3 c/uL.
Erythrocytes: \<0.75 x BL
Sodium (Na): \<0.95 x LLN, \>1.05 x ULN; potassium (K): \<0.9 x LLN, \>1.1 x ULN; chloride (Cl): \<0.9 x LLN, \>1.1 x ULN
Bilirubin: \>2 x ULN; blood urea nitrogen (BUN): \>2 x BL; creatinine: \>4 x BL; calcium (Ca): \<0.8 x LLN, \>1.2 x ULN; phosphorous (P): \<0.75 x LLN, \>1.2 5 x ULN; serum glucose (Glu): \<65 mg/dL, \>220 mg/dL; fasting serum Glu: \<0.8 x LLN, \>1.5 x ULN; uric acid: \>1.5 x ULN;
alanine aminotransferase (ALT): \>3 x ULN; aspartate aminotransferase (AST): \>3 x ULN; G-Glutamyl transferase (GGT): \>2 x ULN; Alkaline phosphatase (ALP): \>2 x ULN
Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), units=mm mercury (Hg)
Heart Rate (HR), units=beats per minute (bpm)
Temperature (T), units=degrees Celcius
| Arm | Type | Description |
|---|---|---|
| Abatacept (ABA) + Methotrexate (MTX) (double-blind [DB]) | ACTIVE_COMPARATOR | Days 1-365 |
| Infliximab + MTX (DB) | ACTIVE_COMPARATOR | Days 1-365 |
| Placebo + MTX (DB) | PLACEBO_COMPARATOR | Days 1-197 |
| Placebo + MTX switched to abatacept + MTX (DB) | EXPERIMENTAL | Participants received placebo plus methotrexate for days 1-197, and abatacept plus methotrexate for days 198-365 |
| Abatacept (open-label) | EXPERIMENTAL | Days 365 to 729 All participants receive Active Drug |
| Name | Type | Description |
|---|---|---|
| Abatacept (ABA) + Methotrexate (MTX), double-blind (DB) | DRUG | Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months. |
| Infliximab (INF) + MTX, DB | DRUG | Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months. |
| Placebo (PLA) + MTX, DB | DRUG | Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. |
| PLA + MTX switched to ABA+ MTX, DB | DRUG | Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months |
| ABA, open-label (OL) | DRUG | Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months |
Inclusion Criteria: * Diagnosis of Rheumatoid Arthritis * At least 3 months prior treatment with Methotrexate (MTX) * At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1 mg/dl * Washout required for other disease modifying anti-rheumatic drugs (DMARDS) Exclusion Cr...
Top 20 of 28 competitors
PLA+ MTX switched to ABA+ MTX, DB is used for the treatment of rheumatoid arthritis. It is an investigational therapy being studied in combination with methotrexate for patients with this condition. The drug is currently in Phase 3 clinical development.
PLA+ MTX switched to ABA+ MTX, DB is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate this therapy for rheumatoid arthritis.
PLA+ MTX switched to ABA+ MTX, DB is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed for this therapy.
PLA+ MTX switched to ABA+ MTX, DB has one completed Phase 3 trial, NCT00095147, titled "Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis." The trial enrolled 431 participants across multiple countries including the United States, Argentina, Australia, and Brazil.
PLA+ MTX switched to ABA+ MTX, DB is a treatment regimen that involves switching from placebo plus methotrexate to abatacept plus methotrexate. The clinical trial NCT00095147 compares abatacept and infliximab, both in combination with methotrexate, for rheumatoid arthritis.