Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

NCT00095147 | Completed Phase 3 Results

• 1 other identifier: IM101-043
• Study Type: interventional
• Target: 431
• Locations: 17 countries
• Sites: 76

Brief Summary

The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (40)

• DB; Adjusted Mean Change From Baseline to Day 197 in Disease Activity Score (DAS) 28 Score (Erythrocyte Sedimentation Rate [ESR]) For ABA Versus PLA (Last Observation Carried Forward [LOCF] Analysis)

  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.

  Baseline (Day 1), 6 months (Day 197)

• OL; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, and AEs Leading to Discontinuation

  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.

  From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)

• OL; Number of Participants With AEs of Special Interest

  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).

  From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)

• OL; Number of Participants With Select Hematologic Laboratory Abnormalities

  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;

  From Day 366 through end of OL (range from 1.9 months to 42.3 months)

• OL; Number of Participants With Select Blood Chemistry Laboratory Abnormalities

  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

  From Day 366 through end of OL (range from 1.9 months to 42.3 months)

• OL; Mean Change From Baseline to Day 365 in Hemoglobin, Total Protein, and Albumin

  Hemoglobin (HGB): \>3 g/dL decrease from BL; total protein: \< 0.9 x LLN, \>1.1 x ULN; albumin:\<0.9 x LLN

  Baseline (Day 1), Day 365

• OL; Mean Change From Baseline to Day 365 in Platelets

  Platelets (PLT): \<0.67 x LLN, \>1.5 x ULN

  Baseline (Day 1), Day 365

• OL; Mean Change From Baseline to Day 365 in Hematocrit

  Hematocrit: \<0.75 x BL

  Baseline (Day 1), Day 365

• OL; Mean Change From Baseline to Day 365 in White Blood Cells

  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.

  Baseline (Day 1), Day 365

• OL; Mean Change From Baseline to Day 365 in Erythrocytes

  Erythrocytes: \<0.75 x BL

  Baseline (Day 1), Day 365

• OL; Mean Change From Baseline to Day 365 in Electrolytes

  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

  Baseline (Day 1), Day 365

• OL; Mean Change From Baseline to Day 365 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid

  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;

  Baseline (Day 1), Day 365

• OL; Mean Change From Baseline to Day 365 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase

  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

  Baseline (Day 1), Day 365

• OL; Mean Change From Baseline to Day 729 in Hemoglobin, Total Protein, and Albumin

  Hemoglobin (HGB): \>3 g/dL decrease from BL; total protein: \< 0.9 x LLN, \>1.1 x ULN; albumin:\<0.9 x LLN

  Baseline (Day 1), Day 729

• OL; Mean Change From Baseline to Day 729 in Platelets

  Platelets (PLT): \<0.67 x LLN, \>1.5 x ULN

  Baseline (Day 1), Day 729

• OL; Mean Change From Baseline to Day 729 in Hematocrit

  Hematocrit: \<0.75 x BL

  Baseline (Day 1), Day 729

• OL; Mean Change From Baseline to Day 729 in White Blood Cells

  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.

  Baseline (Day 1), Day 729

• OL; Mean Change From Baseline to Day 729 in Erythrocytes

  Erythrocytes: \<0.75 x BL

  Baseline (Day 1), Day 729

• OL; Mean Change From Baseline to Day 729 in Electrolytes

  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

  Baseline (Day 1), Day 729

• OL; Mean Change From Baseline to Day 729 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid

  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;

  Baseline (Day 1), Day 729

• OL; Mean Change From Baseline to Day 729 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase

  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

  Baseline (Day 1), Day 729

• OL; Mean Change From Baseline to Day 1121 in Hemoglobin, Total Protein, and Albumin

  Hemoglobin (HGB): \>3 g/dL decrease from BL; total protein: \< 0.9 x LLN, \>1.1 x ULN; albumin:\<0.9 x LLN

  Baseline (Day 1), Day 1121

• OL; Mean Change From Baseline to Day 1121 in Platelets

  Platelets (PLT): \<0.67 x LLN, \>1.5 x ULN

  Baseline (Day 1), Day 1121

• OL; Mean Change From Baseline to Day 1121 in Hematocrit

  Hematocrit: \<0.75 x BL

  Baseline (Day 1), Day 1121

• OL; Mean Change From Baseline to Day 1121 in White Blood Cells

  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.

  Baseline (Day 1), Day 1121

• OL; Mean Change From Baseline to Day 1121 in Erythrocytes

  Erythrocytes: \<0.75 x BL

  Baseline (Day 1), Day 1121

• OL; Mean Change From Baseline to Day 1121 in Electrolytes

  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

  Baseline (Day 1), Day 1121

• OL; Mean Change From Baseline to Day 1121 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid

  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;

  Baseline (Day 1), Day 1121

• OL; Mean Change From Baseline to Day 1121 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase

  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

  Baseline (Day 1), Day 1121

• OL; Mean Change From Baseline to Day 1513 in Hemoglobin, Total Protein, and Albumin

  Hemoglobin (HGB): \>3 g/dL decrease from BL; total protein: \< 0.9 x LLN, \>1.1 x ULN; albumin:\<0.9 x LLN

  Baseline (Day 1), Day 1513

• OL; Mean Change From Baseline to Day 1513 in Platelets

  Platelets (PLT): \<0.67 x LLN, \>1.5 x ULN

  Baseline (Day 1), Day 1513

• OL; Mean Change From Baseline to Day 1513 in Hematocrit

  Hematocrit: \<0.75 x BL

  Baseline (Day 1), Day 1513

• OL; Mean Change From Baseline to Day 1513 in White Blood Cells

  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.

  Baseline (Day 1), Day 1513

• OL; Mean Change From Baseline to Day 1513 in Erythrocytes

  Erythrocytes: \<0.75 x BL

  Baseline (Day 1), Day 1513

• OL; Mean Change From Baseline to Day 1513 in Electrolytes

  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

  Baseline (Day 1), Day 1513

• OL; Mean Change From Baseline to Day 1513 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid

  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;

  Baseline (Day 1), Day 1513

• OL; Mean Change From Baseline to Day 1513 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase

  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

  Baseline (Day 1), Day 1513

• OL; Mean Systolic (SBP) and Diastolic (DBP) Blood Pressure During Open Label Period

  Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), units=mm mercury (Hg)

  Days 365, 729, 1121, and 1513

• OL; Mean Heart Rate (HR) During Open Label Period

  Heart Rate (HR), units=beats per minute (bpm)

  Days 365, 729, 1121, and 1513

• OL; Mean Temperature (T) During Open Label Period

  Temperature (T), units=degrees Celcius

  Days 365, 729, 1121, and 1513

Secondary Outcomes (31)

• DB; Adjusted Mean Change From Baseline to Day 197 in DAS 28 Score (ESR) For INF Versus PLA (LOCF Analysis)

  Baseline (Day 1), 6 months (Day 197)

• DB; DAS 28 (ESR) Area Under The Curve (AUC) Over 12 Months For ABA Versus INF

  From Day 1 through Day 365 (12 months)

• DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 197

  DB Day 197

• DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 365

  DB Day 365

• DB; Adjusted Mean Change From Baseline to Day 197 in HAQ-DI (LOCF Analysis)

  Baseline (Day 1), 6 months (Day 197)

Study Arms (5)

Abatacept (ABA) + Methotrexate (MTX) (double-blind [DB])

ACTIVE COMPARATOR

Days 1-365

Drug: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)

Infliximab + MTX (DB)

ACTIVE COMPARATOR

Days 1-365

Drug: Infliximab (INF) + MTX, DB

Placebo + MTX (DB)

PLACEBO COMPARATOR

Days 1-197

Drug: Placebo (PLA) + MTX, DB

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

Drug: PLA + MTX switched to ABA+ MTX, DB

Abatacept (open-label)

EXPERIMENTAL

Days 365 to 729 All participants receive Active Drug

Drug: ABA, open-label (OL)

Interventions

Abatacept (ABA) + Methotrexate (MTX), double-blind (DB) DRUG

Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months.

Also known as: Orencia

Abatacept (ABA) + Methotrexate (MTX) (double-blind [DB])

Infliximab (INF) + MTX, DB DRUG

Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months.

Infliximab + MTX (DB)

Placebo (PLA) + MTX, DB DRUG

Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months.

Placebo + MTX (DB)

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

Also known as: Orencia

Placebo + MTX switched to abatacept + MTX (DB)

ABA, open-label (OL) DRUG

Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months

Also known as: Orencia

Abatacept (open-label)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• participants who have failed more than 3 DMARDs
• participants previously treated with an approved biologic drug
• History of cancer in the last 5 years
• Severe or recurrent bacterial infection
• Any previous or current medical conditions that are contraindications to the use of TNF blocking agents
• Women of Child Bearing Potential

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (76)

Local Institution

Huntsville, Alabama, United States

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Denver, Colorado, United States

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Boca Raton, Florida, United States

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Fort Lauderdale, Florida, United States

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Largo, Florida, United States

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Indianapolis, Indiana, United States

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New Orleans, Louisiana, United States

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Springfield, Massachusetts, United States

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Worcester, Massachusetts, United States

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Flowood, Mississippi, United States

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Syracuse, New York, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Bethlehem, Pennsylvania, United States

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Willow Grove, Pennsylvania, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Buenos Aires, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Cairns, Queensland, Australia

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Cotton Tree, Queensland, Australia

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Clayton, Victoria, Australia

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Heidelberg, Victoria, Australia

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Malvern, Victoria, Australia

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Parkville, Victoria, Australia

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Perth, Western Australia, Australia

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Curitiba, Paraná, Brazil

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Recife, Pernambuco, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Hamilton, Ontario, Canada

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Kitchener, Ontario, Canada

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

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Ste-Foy, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Kitchener, ON, Canada

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Prague, Czechia

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Copenhagen, Denmark

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Tijuana, Estado de Baja California, Mexico

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León, Guanajuato, Mexico

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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San Luis Potosí City, San Luis Potosí, Mexico

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Lima, Peru

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Poznan, Poland

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Sopot, Poland

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Warsaw, Poland

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Rio Piedras, Puerto Rico

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Moscow, Russia

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Muckleneuk, Gauteng, South Africa

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Berea, KwaZulu-Natal, South Africa

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Panorama, Western Cape, South Africa

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Seoul, South Korea

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A Coruña, Spain

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Barcelona, Spain

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Córdoba, Spain

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Madrid, Spain

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Falun, Sweden

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Linköping, Sweden

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Lund, Sweden

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Stockholm, Sweden

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Uppsala, Sweden

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Bern, Switzerland

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Sankt Gallen, Switzerland

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Related Publications (1)

• Schiff M, Keiserman M, Codding C, Songcharoen S, Berman A, Nayiager S, Saldate C, Li T, Aranda R, Becker JC, Lin C, Cornet PL, Dougados M. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis. 2008 Aug;67(8):1096-103. doi: 10.1136/ard.2007.080002. Epub 2007 Nov 29.

  PMID: 18055472 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept; Methotrexate; Double-Blind Method; Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Antibodies, Monoclonal; Immunoproteins

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2004
• First Posted: November 2, 2004
• Study Start: February 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 24, 2015
• Results First Posted: January 21, 2011

Record last verified: 2015-03

Locations

US (19); BR (5); CZ (1); AU (7); SE (5); ES (4); KR (1); ME (6); PE (1); CH (2); CA (11); RU (1); AR (5); ZA (3); DK (1); PL (3); PR (1)