Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

• ClinicalTrials.gov Identifier: NCT01500278
• Recruitment Status: Completed
• First Posted: December 28, 2011
• Results First Posted: March 31, 2017
• Last Update Posted: July 31, 2018
• Sponsor: UCB Pharma SA
• Collaborator: Parexel
• Information provided by (Responsible Party): UCB Pharma ( UCB Pharma SA )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Interventions: Biological: Certolizumab Pegol (CZP); Biological: Adalimumab (ADA); Drug: Methotrexate (MTX)
• Enrollment: 915

Participant Flow

Recruitment Details	The study started to enroll patients in December 2011 and concluded in January 2016.
Pre-assignment Details	Participant Flow refers to the Randomized Treatment Group (RTG) that consisted of all subjects randomized into the study.

Arm/Group Title	CZP+MTX (RTG)	ADA+MTX (RTG)
Arm/Group Description	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did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.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.	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.
Period Title: Week 0 - Week 12
Started	457	458
Completed	426	428
Not Completed	31	30
Reason Not Completed
Lack of Efficacy	0	1
Protocol Violation	10	16
Lost to Follow-up	1	1
Withdrawal by Subject	7	2
Protocol violation on screening X-ray	1	0
Patient decision	1	0
Exclusion criteria not met	1	0
Investigator decision	1	0
Prior history of serious disease	1	0
Sponsor decision	1	0
Personal reason	0	1
Other serious disease	0	1
Adverse event (AE), not fatal	7	8
Period Title: Week 13 - Week 104
Started	426	428
Completed	287	302
Not Completed	139	126
Reason Not Completed
Lack of Efficacy	11	12
Protocol Violation	6	6
Lost to Follow-up	6	5
Withdrawal by Subject	22	13
Week 24 Non-Responder	20	16
Non/bad compliance	7	5
Recurrent infections	1	0
False positive test	1	2
Sponsor request	4	0
Withdrawn in error	1	0
Exclusion criteria not met	1	0
Protocol deviation	1	0
Principal investigator retiring	1	0
Patient declined Safety Follow Up Visit	1	0
Abnormal questionable chest X-ray	0	2
Relocation	0	1
Sponsor decision	0	2
Medical monitor decision	0	2
Personal reason	0	1
Not completed	0	1
Death	2	4
Adverse Event	54	54

Baseline Characteristics

Arm/Group Title		CZP+MTX (RTG)	ADA+MTX (RTG)	Total Title
Arm/Group Description		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.	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.	[Not Specified]
Overall Number of Baseline Participants		457	458	915
Baseline Analysis Population Description		Baseline Characteristics refer to the Randomized Treatment Group (RTG) that consisted of all subjects randomized into the study.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	457 participants	458 participants	915 participants
	<=18 years	0 0.0%	1 0.2%	1 0.1%
	Between 18 and 65 years	364 79.6%	372 81.2%	736 80.4%
	>=65 years	93 20.4%	85 18.6%	178 19.5%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
Arithmetic mean (standard deviation)	Number Analyzed	457 participants	458 participants	915 participants
		53.5 (12.3)	52.9 (12.8)	53.2 (12.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	457 participants	458 participants	915 participants
	Female	360 78.8%	363 79.3%	723 79.0%
	Male	97 21.2%	95 20.7%	192 21.0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12
Description	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).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CZP+MTX (FAS)	ADA+MTX (FAS)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	454	454
Measure Type: Number; Unit of Measure: Percentage of subjects
	69.2	71.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CZP+MTX (FAS), ADA+MTX (FAS)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	=0.467
	Comments	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.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.67 to 1.20
	Estimation Comments	[Not Specified]

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CZP+MTX (FAS)	ADA+MTX (FAS)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	454	454
Measure Type: Number; Unit of Measure: Percentage of subjects
	35.5	33.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CZP+MTX (FAS), ADA+MTX (FAS)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	=0.532
	Comments	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 Baseline DAS28(ESR) and age as covariates.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.45
	Estimation Comments	[Not Specified]

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CZP+MTX (Week 12 Responder Set)	ADA+MTX (Week 12 Responder Set)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	353	361
Measure Type: Number; Unit of Measure: Percentage of subjects
	45.6	42.4

4. Secondary Outcome

Title	Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 6
Description	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).
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CZP+MTX (FAS)	ADA+MTX (FAS)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	454	454
Measure Type: Number; Unit of Measure: Percentage of subjects
	64.5	60.8

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CZP+MTX (FAS)	ADA+MTX (FAS)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	454	454
Measure Type: Number; Unit of Measure: Percentage of subjects
	20.5	18.1

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CZP+MTX (FAS)	ADA+MTX (FAS)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	454	454
Measure Type: Number; Unit of Measure: Percentage of subjects
	30.4	29.7

7. Secondary Outcome

Title	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
Description	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 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.
Time Frame	Week 104

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CZP+MTX (Week 12 Responder Set)	ADA+MTX (Week 12 Responder Set)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	310	298
Measure Type: Number; Unit of Measure: Percentage of subjects
	47.7	46.6

8. Secondary Outcome

Title	Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 104
Description	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.
Time Frame	From Baseline to Week 104

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CZP+MTX (FAS)	ADA+MTX (FAS)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	454	454
Least Squares Mean (Standard Error); Unit of Measure: Units on a Scale
	-0.62 (0.03)	-0.72 (0.03)

9. Secondary Outcome

Title	Kaplan-Meier Estimates of Proportion of Subjects Who Discontinued After Response at Week 12
Description	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).
Time Frame	From Week 12 up to Week 104

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CZP+MTX (Week 12 Responder Set)	ADA+MTX (Week 12 Responder Set)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	353	361
Measure Type: Number; Unit of Measure: proportion of subjects
Week 13 (Day 7)	0	0.0028
Week 26 (Day 98)	0.0198	0.0332
Week 39 (Day 189)	0.0453	0.0609
Week 52 (Day 280)	0.0963	0.0886
Week 65 (Day 371)	0.1643	0.1607
Week 78 (Day 462)	0.2181	0.1967
Week 91 (Day 553)	0.2408	0.2105
Week 104 (Day 644)	0.2635	0.2247

Adverse Events

Time Frame	During the entire study period (From Week -4 to Week 104).
Adverse Event Reporting Description	The AEs of subjects who switched study treatment at Week 12 (W12) were presented under the original treatment group if they occurred after the 1st administration of study treatment (W0) until the day before W12 treatment administration, and were presented under the switched treatment group if they occurred after the W12 treatment administration up to and including 70 days after the last injection. Subjects who switched treatment at W12 were included in both CZP+MTX(SS) and ADA+MTX(SS) group.
Arm/Group Title	CZP+MTX (SS)		ADA+MTX (SS)
Arm/Group Description	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.		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.
All-Cause Mortality
	CZP+MTX (SS)		ADA+MTX (SS)
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	CZP+MTX (SS)		ADA+MTX (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	67/516 (12.98%)		58/523 (11.09%)
Blood and lymphatic system disorders
Anaemia * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Cardiac disorders
Aortic valve incompetence * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Aortic valve stenosis * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Stress cardiomyopathy * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Coronary artery disease * 1	2/516 (0.39%)	2	0/523 (0.00%)	0
Cardiac failure congestive * 1	1/516 (0.19%)	1	1/523 (0.19%)	1
Cardiogenic shock * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Angina unstable * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Myocardial infarction * 1	1/516 (0.19%)	1	1/523 (0.19%)	1
Myocardial ischaemia * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Pericardial effusion * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Bradycardia * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Atrial fibrillation * 1	2/516 (0.39%)	2	0/523 (0.00%)	0
Supraventricular tachycardia * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Cardiac arrest * 1	1/516 (0.19%)	1	1/523 (0.19%)	1
Eye disorders
Ophthalmic vein thrombosis * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Diplopia * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Gastrointestinal disorders
Obstruction gastric * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Chronic gastritis * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Gastritis * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Abdominal pain upper * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Irritable bowel syndrome * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Intestinal stenosis * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Anorectal varices * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
General disorders
Sudden death * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Impaired healing * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Systemic inflammatory response syndrome * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Chest pain * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Non-cardiac chest pain * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Hepatobiliary disorders
Cholecystitis acute * 1	1/516 (0.19%)	1	2/523 (0.38%)	2
Cholelithiasis * 1	0/516 (0.00%)	0	4/523 (0.76%)	4
Hepatotoxicity * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Drug-induced liver injury * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Infections and infestations
Appendicitis * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Appendicitis perforated * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Diverticulitis * 1	1/516 (0.19%)	1	1/523 (0.19%)	1
Perirectal abscess * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Bronchopulmonary aspergillosis * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Mycobacterial infection * 1	2/516 (0.39%)	2	0/523 (0.00%)	0
Bronchitis bacterial * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Pneumonia bacterial * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Cellulitis * 1	0/516 (0.00%)	0	2/523 (0.38%)	2
Clostridium difficile infection * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Oophoritis * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Hepatitis A * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Herpes zoster * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Respiratory tract infection * 1	1/516 (0.19%)	1	1/523 (0.19%)	1
Pneumonia * 1	6/516 (1.16%)	6	5/523 (0.96%)	5
Sepsis * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Subcutaneous abscess * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Skin infection * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Disseminated tuberculosis * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Pyelonephritis * 1	2/516 (0.39%)	2	0/523 (0.00%)	0
Urinary tract infection * 1	2/516 (0.39%)	2	1/523 (0.19%)	1
Pyelonephritis acute * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Viral infection * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Injury, poisoning and procedural complications
Joint injury * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Subdural heamatoma * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Joint dislocation * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Lower limb fracture * 1	2/516 (0.39%)	2	0/523 (0.00%)	0
Humerus fracture * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Wrist fracture * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Ancle fracture * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Femoral neck fracture * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Hand fracture * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Hip fracture * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Contusion * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Thoracic vertebral fracture * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Cervical vertebral fracture * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Musculoskeletal and connective tissue disorders
Arthropathy * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Arthritis * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Bone disorder * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Osteonecrosis * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Foot deformity * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Invertebral disc protrusion * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Joint effusion * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Joint swelling * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Torticollis * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Osteoarthritis * 1	2/516 (0.39%)	2	1/523 (0.19%)	1
Rheumatoid arthritis * 1	3/516 (0.58%)	3	1/523 (0.19%)	1
Lumbar spinal stenosis * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Tendon disorder * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Bladder cancer * 1	1/516 (0.19%)	1	1/523 (0.19%)	1
Invasive ductal breast carcinoma * 1	1/516 (0.19%)	1	1/523 (0.19%)	1
Borderline mucinous tumour of ovary * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Chronic myeloid leukaemia * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Lung adenocarcinoma * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Ovarian adenoma * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Renal cancer * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Basal cell carcinoma * 1	1/516 (0.19%)	1	1/523 (0.19%)	1
Thyroid cancer * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Uterine leiomyoma * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Nervous system disorders
Cerebral haematoma * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Cerebral ischaemia * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Cerebrovascular accident * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Ischaemic stroke * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Coma * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Syncope * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Generalised tonic-clonic seizure * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Amnesia * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Post herpetic neuralgia * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Transient ischaemic attack * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Pregnancy, puerperium and perinatal conditions
Abortion * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Pregnancy with contraceptive device * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Psychiatric disorders
Adjustment disorder * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Anxiety disorder * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Bipolar disorder * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Renal and urinary disorders
Nephrolithiasis * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Reproductive system and breast disorders
Cervical dysplasia * 1	0/516 (0.00%)	0	2/523 (0.38%)	2
Menorrhagia * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Respiratory, thoracic and mediastinal disorders
Asthma * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Pneumonia aspiration * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Nasal polyps * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Interstitial lung disease * 1	2/516 (0.39%)	2	0/523 (0.00%)	0
Pulmonary embolism * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Acute respiratory failure * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Respiratory failure * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Surgical and medical procedures
Osteosynthesis * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Hip arthroplasty * 1	0/516 (0.00%)	0	1/523 (0.19%)	1
Vascular disorders
Venous thrombosis * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Peripheral venous disease * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Deep vein thrombosis * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
Venous thrombosis limb * 1	1/516 (0.19%)	1	0/523 (0.00%)	0
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA18.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	CZP+MTX (SS)		ADA+MTX (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	269/516 (52.13%)		244/523 (46.65%)
Gastrointestinal disorders
Diarrhoea * 1	31/516 (6.01%)	36	23/523 (4.40%)	26
Infections and infestations
Nasopharyngitis * 1	79/516 (15.31%)	116	67/523 (12.81%)	106
Upper respiratory tract infection * 1	53/516 (10.27%)	74	60/523 (11.47%)	80
Urinary tract infection * 1	43/516 (8.33%)	58	51/523 (9.75%)	65
Latent tuberculosis * 1	31/516 (6.01%)	31	27/523 (5.16%)	27
Sinusitis * 1	31/516 (6.01%)	35	21/523 (4.02%)	31
Bronchitis * 1	29/516 (5.62%)	33	25/523 (4.78%)	26
Nervous system disorders
Headache * 1	55/516 (10.66%)	62	47/523 (8.99%)	77
Respiratory, thoracic and mediastinal disorders
Cough * 1	21/516 (4.07%)	26	28/523 (5.35%)	35
Vascular disorders
Hypertension * 1	37/516 (7.17%)	42	31/523 (5.93%)	34
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA18.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: UCB
• Organization: Cares
• Phone: +1877 822 ext 9493

Publications of Results:

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. Erratum In: Lancet. 2017 Feb 4;389(10068):e2.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1.

• Responsible Party: UCB Pharma ( UCB Pharma SA )
• ClinicalTrials.gov Identifier: NCT01500278
• Other Study ID Numbers: RA0077; 2011-002067-20 ( EudraCT Number )
• First Submitted: December 22, 2011
• First Posted: December 28, 2011
• Results First Submitted: November 22, 2016
• Results First Posted: March 31, 2017
• Last Update Posted: July 31, 2018