Study to Assess the Short- and Long-term Efficacy of Cert... | NCT01500278

NCT01500278

ID	Type	Description	Link
2011-002067-20	EudraCT Number

Status Module

Name	Class
Parexel	INDUSTRY

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Certolizumab Pegol + Methotrexate (CZP + MTX)	Active Comparator		Biological: Certolizumab Pegol (CZP) Drug: Methotrexate (MTX)
Adalimumab + Methotrexate (ADA + MTX)	Active Comparator		Biological: Adalimumab (ADA) Drug: Methotrexate (MTX)
CZP + MTX followed by ADA + MTX	Active Comparator	Those subjects who received Certolizumab Pegol (400 mg at Weeks 0, 2, 4 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) at Baseline and are Non-Responders at Week 12, switch to Adalimumab (40 mg) + Methotrexate (ADA + MTX) after Week 12.	Biological: Certolizumab Pegol (CZP) Biological: Adalimumab (ADA) Drug: Methotrexate (MTX)
ADA + MTX followed by CZP + MTX	Active Comparator	Those subjects who received Adalimumab (40 mg + Placebo at Weeks 0, 2, 4 followed by 40 mg ADA every two weeks) + Methotrexate (ADA+ MTX) at Baseline and are Non-Responders at Week 12, switch to Certolizumab Pegol (400 mg at Weeks 12, 14, 16 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) after Week 12.	Biological: Certolizumab Pegol (CZP) Biological: Adalimumab (ADA) Drug: Methotrexate (MTX)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Certolizumab Pegol (CZP)	Biological	Active substance: an injectable volume of 1 ml solution for injection CZP Pharmaceutical form: prefilled syringes CZP Concentration: 200 mg/ml CZP Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12	Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).	Week 12
Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104	DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.	Week 104

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Week 12 Responders Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104	DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity. The definition of Week 12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline.

Eligibility Module

Name	Affiliation	Role
UCB Cares	+1 877 822 9493 (UCB)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
141		Birmingham	Alabama		United States
214

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27863807	Result	Smolen JS, Burmester GR, Combe B, Curtis JR, Hall S, Haraoui B, van Vollenhoven R, Cioffi C, Ecoffet C, Gervitz L, Ionescu L, Peterson L, Fleischmann R. Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study. Lancet. 2016 Dec 3;388(10061):2763-2774. doi: 10.1016/S0140-6736(16)31651-8. Epub 2016 Nov 15.
39222436

Label	URL
FDA Safety Alerts and Recalls	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	CZP+MTX (RTG)	Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10. Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102. Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	CZP+MTX (RTG)	Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10. Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102. Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.
BG001	ADA+MTX (RTG)	Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4. Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102. Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.
BG002	Total Title

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0011 BG0021
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Arithmetic mean (standard deviation)

Title	Measurements
	BG00053.5± 12.3 BG00152.9± 12.8 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000360 BG001363 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12

Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).

The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.

Posted

Number

Percentage of subjects

Week 12

ID	Title	Description
OG000	CZP+MTX (FAS)	Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10. Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102. Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.
OG001	ADA+MTX (FAS)	Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4. Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102. Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Units	Counts
Participants	OG000454 OG001454

Title

Denominators

Categories

Title	Measurements
	OG00069.2 OG00171.4

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		=0.467	The odds ratio, CI, and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (<2 years or >=2 years), and geographic region as factors and age as a covariate.	Odds Ratio (OR)	0.90			2-Sided	95	0.67	1.20					Superiority or Other

Primary

Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104

DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.

The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.

Posted

Number

Percentage of subjects

Week 104

ID	Title	Description
OG000	CZP+MTX (FAS)	Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10. Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102. Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.
OG001

Secondary

Percentage of Week 12 Responders Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104

The definition of Week 12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline.

Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12.

Posted

Number

Percentage of subjects

Week 104

ID	Title	Description
OG000	CZP+MTX (Week 12 Responder Set)	CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.
OG001	ADA+MTX (Week 12 Responder Set)	ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Secondary

Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 6

The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.

Posted

Number

Percentage of subjects

Week 6

ID	Title	Description
OG000	CZP+MTX (FAS)	Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10. Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102. Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Secondary

Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 6

The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.

Posted

Number

Percentage of subjects

Week 6

ID	Title	Description
OG000	CZP+MTX (FAS)	Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10. Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102. Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.
OG001

Secondary

Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12

The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.

Posted

Number

Percentage of subjects

Week 12

ID	Title	Description
OG000	CZP+MTX (FAS)	Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10. Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102. Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.
OG001

Secondary

Percentage of Subjects With a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104, in Subjects Responding at Both Week 6 and Week 12

The definition of Week 6/12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline.

Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12. Only subjects responding at both Week 6 and Week 12 are included in this analysis.

Posted

Number

Percentage of subjects

Week 104

ID	Title	Description
OG000	CZP+MTX (Week 12 Responder Set)	CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.
OG001	ADA+MTX (Week 12 Responder Set)

Secondary

Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 104

HAQ-DI was derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), and the total HAQ-DI was scored on the scale of 0-3 as well. Change from Baseline was computed as the value at Week 104 minus the Baseline value. A negative value in Change from Baseline indicates an improvement.

The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.

Posted

Least Squares Mean

Standard Error

Units on a Scale

From Baseline to Week 104

ID	Title	Description
OG000	CZP+MTX (FAS)	Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10. Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102. Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Secondary

Kaplan-Meier Estimates of Proportion of Subjects Who Discontinued After Response at Week 12

Response at Week 12 means that a subject had either a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12 or had a reduction of DAS28 [ESR] ≥ 1.2 from Baseline to Week 12. Kaplan-Meier Estimates of Proportion of Subjects Discontinued are presented per study week (days relative to Week 12 visit).

Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12.

Posted

Number

proportion of subjects

From Week 12 up to Week 104

ID	Title	Description
OG000	CZP+MTX (Week 12 Responder Set)	CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.
OG001	ADA+MTX (Week 12 Responder Set)	ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding. All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CZP+MTX (SS)	All subjects who received at least 1 dose of Certolizumab pegol (CZP). All adverse events that occurred when the subject was receiving CZP treatment are summarized in this group.			67	516	269	516
EG001	ADA+MTX (SS)	All subjects who received at least 1 dose of Adalimumab (ADA). All adverse events that occurred when the subject was receiving ADA treatment are summarized in this group.			58	523	244	523

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Coronary artery disease	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0002 events2 affected516 at risk EG0010 events0 affected523 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0011 events1 affected523 at risk
Cardiogenic shock	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Angina unstable	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Myocardial infarction	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0011 events1 affected523 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Pericardial effusion	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Bradycardia	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Atrial fibrillation	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0002 events2 affected516 at risk EG0010 events0 affected523 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Cardiac arrest	Cardiac disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0011 events1 affected523 at risk
Ophthalmic vein thrombosis	Eye disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Diplopia	Eye disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Gastritis	Gastrointestinal disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Intestinal stenosis	Gastrointestinal disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Anorectal varices	Gastrointestinal disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Sudden death	General disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Impaired healing	General disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Chest pain	General disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Non-cardiac chest pain	General disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0012 events2 affected523 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0014 events4 affected523 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Appendicitis	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Appendicitis perforated	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Diverticulitis	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0011 events1 affected523 at risk
Perirectal abscess	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Mycobacterial infection	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0002 events2 affected516 at risk EG0010 events0 affected523 at risk
Bronchitis bacterial	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Pneumonia bacterial	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Cellulitis	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0012 events2 affected523 at risk
Clostridium difficile infection	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Oophoritis	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Hepatitis A	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Herpes zoster	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Respiratory tract infection	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0011 events1 affected523 at risk
Pneumonia	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0006 events6 affected516 at risk EG0015 events5 affected523 at risk
Sepsis	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Subcutaneous abscess	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Skin infection	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Pyelonephritis	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0002 events2 affected516 at risk EG0010 events0 affected523 at risk
Urinary tract infection	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0002 events2 affected516 at risk EG0011 events1 affected523 at risk
Pyelonephritis acute	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Viral infection	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Subdural heamatoma	Injury, poisoning and procedural complications	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA18.1	Non-systematic Assessment	EG0002 events2 affected516 at risk EG0010 events0 affected523 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Ancle fracture	Injury, poisoning and procedural complications	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Bone disorder	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Invertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0002 events2 affected516 at risk EG0011 events1 affected523 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0003 events3 affected516 at risk EG0011 events1 affected523 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0011 events1 affected523 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0011 events1 affected523 at risk
Borderline mucinous tumour of ovary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0011 events1 affected523 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Cerebral haematoma	Nervous system disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Ischaemic stroke	Nervous system disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Coma	Nervous system disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Syncope	Nervous system disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Amnesia	Nervous system disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Abortion	Pregnancy, puerperium and perinatal conditions	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Pregnancy with contraceptive device	Pregnancy, puerperium and perinatal conditions	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Adjustment disorder	Psychiatric disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Anxiety disorder	Psychiatric disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Bipolar disorder	Psychiatric disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0012 events2 affected523 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA18.1	Non-systematic Assessment	EG0002 events2 affected516 at risk EG0010 events0 affected523 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Osteosynthesis	Surgical and medical procedures	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA18.1	Non-systematic Assessment	EG0000 events0 affected516 at risk EG0011 events1 affected523 at risk
Venous thrombosis	Vascular disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Peripheral venous disease	Vascular disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Deep vein thrombosis	Vascular disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk
Venous thrombosis limb	Vascular disorders	MedDRA18.1	Non-systematic Assessment	EG0001 events1 affected516 at risk EG0010 events0 affected523 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA18.1	Non-systematic Assessment	EG00036 events31 affected516 at risk EG00126 events23 affected523 at risk
Nasopharyngitis	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG000116 events79 affected516 at risk EG001106 events67 affected523 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG00074 events53 affected516 at risk EG00180 events60 affected523 at risk
Urinary tract infection	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG00058 events43 affected516 at risk EG00165 events51 affected523 at risk
Latent tuberculosis	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG00031 events31 affected516 at risk EG00127 events27 affected523 at risk
Sinusitis	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG00035 events31 affected516 at risk EG00131 events21 affected523 at risk
Bronchitis	Infections and infestations	MedDRA18.1	Non-systematic Assessment	EG00033 events29 affected516 at risk EG00126 events25 affected523 at risk
Headache	Nervous system disorders	MedDRA18.1	Non-systematic Assessment	EG00062 events55 affected516 at risk EG00177 events47 affected523 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA18.1	Non-systematic Assessment	EG00026 events21 affected516 at risk EG00135 events28 affected523 at risk
Hypertension	Vascular disorders	MedDRA18.1	Non-systematic Assessment	EG00042 events37 affected516 at risk EG00134 events31 affected523 at risk

Ancestor Terms

ID	Term
D011092	Polyethylene Glycols
D011108	Polymers
D046911	Macromolecular Substances
D007140	Immunoglobulin Fab Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D000068582	Certolizumab Pegol
D000068879	Adalimumab
D008727	Methotrexate