Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis

• ClinicalTrials.gov Identifier: NCT02640612
• Recruitment Status: Completed
• First Posted: December 29, 2015
• Results First Posted: December 5, 2018
• Last Update Posted: December 5, 2018
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Arthritis, Rheumatoid
• Intervention: Drug: BI 695501
• Enrollment: 430

Participant Flow

Recruitment Details	This study was an open-label extension trial. Adult patients with moderate to severely active rheumatoid arthritis (RA) who completed Trial NCT02137226 (1297.2), wished to participate in this extension trial and per Investigator's assessment could benefit from continuing to receive BI 695501 were included in this trial.
Pre-assignment Details	All patients were screened for eligibility to participate in the trial. The screening visit of this trial was the Week 48 visit in Trial 1297.2.

Arm/Group Title	BI 695501 to BI 695501	Humira® to Humira®	Humira® to BI 695501
Arm/Group Description	Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
Period Title: Overall Study
Started	225	103	102
Completed	203	89	96
Not Completed	22	14	6
Reason Not Completed
Adverse Event	6	7	2
Death	1	0	0
Withdrawal by Subject	10	3	3
Lost to Follow-up	4	1	1
Protocol Violation	0	2	0
Lack of Efficacy	1	1	0

Baseline Characteristics

Arm/Group Title		BI 695501 to BI 695501	Humira® to Humira®	Humira® to BI 695501	Total
Arm/Group Description		Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.	Total of all reporting groups
Overall Number of Baseline Participants		225	103	102	430
Baseline Analysis Population Description		Safety Analysis Set (SAF): All patients who received at least 1 dose during trial 1297.3. In the event of doubt as to whether a patient was treated or not, they were assumed to have been treated for the purposes of analysis, and thus included in the SAF. Patients were classified according to randomized/re-randomized treatments of Trial 1297.2.
Age, Continuous [1] [2]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	225 participants	103 participants	102 participants	430 participants
		53.8 (11.87)	51.7 (11.21)	54.6 (9.90)	53.5 (11.30)
		[1] Measure Description: Age of all patients included in the trial; [2] Measure Analysis Population Description: SAF
Sex: Female, Male [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	225 participants	103 participants	102 participants	430 participants
	Female	188 83.6%	88 85.4%	84 82.4%	360 83.7%
	Male	37 16.4%	15 14.6%	18 17.6%	70 16.3%
		[1] Measure Description: Gender distribution of all patients included in the trial.; [2] Measure Analysis Population Description: SAF
Ethnicity (NIH/OMB) [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	225 participants	103 participants	102 participants	430 participants
	Hispanic or Latino	23 10.2%	8 7.8%	10 9.8%	41 9.5%
	Not Hispanic or Latino	199 88.4%	94 91.3%	92 90.2%	385 89.5%
	Unknown or Not Reported	3 1.3%	1 1.0%	0 0.0%	4 0.9%
		[1] Measure Description: Ethnicity of all patients included in the trial; [2] Measure Analysis Population Description: SAF
Race (NIH/OMB) [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	225 participants	103 participants	102 participants	430 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	7 3.1%	2 1.9%	0 0.0%	9 2.1%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	3 1.3%	0 0.0%	2 2.0%	5 1.2%
	White	215 95.6%	100 97.1%	100 98.0%	415 96.5%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	1 1.0%	0 0.0%	1 0.2%
		[1] Measure Description: Race of all patients included in the trial; [2] Measure Analysis Population Description: SAF

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients With Drug-related Adverse Events (AEs) During the Treatment Phase
Description	The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). Thus, all AEs with an onset after the first dose of trial drug up to a period of ten weeks after the last dose of trial drug were assigned to the current treatment for evaluation. Investigator assessed drug related AEs were AEs with a relationship to drug ticked "yes" according to the Investigator.
Time Frame	From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks.

Outcome Measure Data

Analysis Population Description

Safety Analysis Set (SAF): All patients who received at least 1 dose during trial 1297.3. In the event of doubt as to whether a patient was treated or not, they were assumed to have been treated for the purposes of analysis, and thus included in the SAF. Patients were classified according to randomized/re-randomized treatments of Trial 1297.2.

Arm/Group Title	BI 695501 to BI 695501	Humira® to Humira®	Humira® to BI 695501
Arm/Group Description:	Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
Overall Number of Participants Analyzed	225	103	102
Measure Type: Number; Unit of Measure: Percentage of patients (%)
	21.3	20.4	17.6

2. Secondary Outcome

Title	Change From Baseline in Disease Activity Score in 28 Joints (DAS 28) by Erythrocyte Sedimentation Rate (ESR) at Week 48
Description	The DAS28 (ESR) score was derived using the following formulae: DAS28 (ESR) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.7*ln(ESR) Where: • TJC28 = 28 joint count for tenderness • SJC28 = 28 joint count for swelling • GH = General Health component of the DAS (patient's global assessment of disease activity) • Ln (ESR) = natural logarithm of ESR. Last observation carried forward (LOCF) is the method used for handling missing components post baseline. Baseline for this trial was taken from the baseline of 1297.2. Improvement in DAS28 was also categorized using the European League Against Rheumatism (EULAR) response criteria. The DAS28 provides a number on a scale from 0 to 10 where higher values mean a higher disease activity. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.
Time Frame	Baseline and Week 48.

Outcome Measure Data

Analysis Population Description

FullAnalysisSet(FAS) includes patients from the all subjects assigned set who received at least 1 dose of trial drug in Trial 1297.3 and had at least 1 DAS28(ESR and C-reactive protein) or american college of rheumatology 20% response criteria (ACR20) measured during trial. Classified according to randomized/rerandomized treatments of trial 1297.2.

Arm/Group Title	BI 695501 to BI 695501	Humira® to Humira®	Humira® to BI 695501
Arm/Group Description:	Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
Overall Number of Participants Analyzed	225	103	101
Mean (Standard Deviation); Unit of Measure: Unit on scale
	-3.01 (1.385)	-2.91 (1.323)	-2.98 (1.218)

3. Secondary Outcome

Title	Percentage of Patients Meeting American College of Rheumatology (ACR) 20% Response Criteria at Week 48
Description	The proportion of patients meeting the ACR20 response criteria was assessed. A patient had an ACR20 response if all of the following occurred: A ≥ 20 % improvement in the swollen joint count (66 joints), A ≥ 20 % improvement in the tender joint count (68 joints), A ≥ 20 % improvement in at least three of the following assessments: Patient's assessment of pain, Patient's global assessment of disease activity (equivalent to the General Health component of the Disease Activity Score ([DAS]), Physician's global assessment of disease activity, Patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) Acute phase reactant (C-reactive protein [CRP]).
Time Frame	Week 48.

Outcome Measure Data

Analysis Population Description

FAS, All patients who discontinue treatment, are lost-to-follow-up or have any severe violation related to any therapy that may significantly impact efficacy assessment prior to the secondary endpoint assessment will be considered as a non-responder (NRI).

Arm/Group Title	BI 695501 to BI 695501	Humira® to Humira®	Humira® to BI 695501
Arm/Group Description:	Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
Overall Number of Participants Analyzed	225	103	101
Measure Type: Number; Unit of Measure: Percentage of patients (%)
	76.9	76.7	73.3

4. Secondary Outcome

Title	Percentage of Patients Who Meet the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) Definition of Remission at Week 48
Description	The ACR/EULAR remission criteria were based on a Boolean definition. At any time point, the patient must have satisfied all of the following: Tender joint count (TJC) ≤ 1; Swollen joint count (SJC) ≤ 1; C-reactive protein (CRP) ≤ 1 mg/dL; Patient global assessment of disease activity ≤ 10 (on a 0 to 100 scale) For TJC and SJC, use of a 28-joint count may have missed actively involved joints, particularly in the feet and ankles. It was preferable to include the feet and ankles when evaluating remission.
Time Frame	Week 48.

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	BI 695501 to BI 695501	Humira® to Humira®	Humira® to BI 695501
Arm/Group Description:	Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
Overall Number of Participants Analyzed	225	103	101
Measure Type: Number; Unit of Measure: Percentage of patients (%)
	8.4	9.7	6.9

5. Secondary Outcome

Title	Percentage of Patients With European League Against Rheumatism (EULAR) Response (Good Response, Moderate Response, or no Response) at Week 48
Description	Percentage of patients with European League Against Rheumatism (EULAR) response (good response, moderate response, or no response) were calculated at Week 48 for assessment of this outcome measure. No response: If improvement in DAS28 (ESR) at w48 <=0.6, or if DAS28(ESR) at w48 >5.1 and improvement is in range >0.6 to <1.2. Moderate response: If DAS28(ESR) at w48 <=5.1 and improvement is in range >0.6 to <1.2, or, DAS28(ESR) at w48 >3.2 and improvement is in range >=1.2. Good response: If DAS28(ESR) at w48 <=3.2 and improvement >=1.2.
Time Frame	Week 48.

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	BI 695501 to BI 695501	Humira® to Humira®	Humira® to BI 695501
Arm/Group Description:	Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
Overall Number of Participants Analyzed	225	103	101
Measure Type: Number; Unit of Measure: Percentage of patients (%)
Good Response	37.8	37.9	41.6
Moderate Response	49.8	54.4	51.5
No Response	9.3	5.8	3.0

Adverse Events

Time Frame	From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks.
Adverse Event Reporting Description	An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. SAF was used for AE assessment.
Arm/Group Title	BI 695501 to BI 695501	Humira® to Humira®	Humira® to BI 695501
Arm/Group Description	Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.	Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48.
All-Cause Mortality
	BI 695501 to BI 695501	Humira® to Humira®	Humira® to BI 695501
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Serious Adverse Events
	BI 695501 to BI 695501	Humira® to Humira®	Humira® to BI 695501
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	14/225 (6.22%)	8/103 (7.77%)	4/102 (3.92%)
Cardiac disorders
Cardiopulmonary failure † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Gastrointestinal disorders
Abdominal pain † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Abdominal pain upper † 1	0/225 (0.00%)	1/103 (0.97%)	0/102 (0.00%)
Ileus paralytic † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Incarcerated inguinal hernia † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Small intestinal obstruction † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Umbilical hernia † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
General disorders
Non-cardiac chest pain † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Hepatobiliary disorders
Bile duct stenosis † 1	0/225 (0.00%)	1/103 (0.97%)	0/102 (0.00%)
Infections and infestations
Appendicitis † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Clostridium difficile colitis † 1	0/225 (0.00%)	0/103 (0.00%)	1/102 (0.98%)
Gastroenteritis † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Otitis media † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Pneumonia † 1	4/225 (1.78%)	0/103 (0.00%)	0/102 (0.00%)
Pulmonary tuberculosis † 1	0/225 (0.00%)	1/103 (0.97%)	0/102 (0.00%)
Pyelonephritis chronic † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Sepsis † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Staphylococcal sepsis † 1	0/225 (0.00%)	1/103 (0.97%)	0/102 (0.00%)
Injury, poisoning and procedural complications
Femur fracture † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Musculoskeletal and connective tissue disorders
Pathological fracture † 1	0/225 (0.00%)	0/103 (0.00%)	1/102 (0.98%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Basal cell carcinoma † 1	0/225 (0.00%)	1/103 (0.97%)	0/102 (0.00%)
Benign soft tissue neoplasm † 1	0/225 (0.00%)	1/103 (0.97%)	0/102 (0.00%)
Ovarian cancer † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Reproductive system and breast disorders
Endometrial hyperplasia † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Uterine polyp † 1	0/225 (0.00%)	0/103 (0.00%)	1/102 (0.98%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † 1	1/225 (0.44%)	0/103 (0.00%)	0/102 (0.00%)
Interstitial lung disease † 1	0/225 (0.00%)	1/103 (0.97%)	0/102 (0.00%)
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura † 1	0/225 (0.00%)	0/103 (0.00%)	1/102 (0.98%)
Vascular disorders
Deep vein thrombosis † 1	0/225 (0.00%)	1/103 (0.97%)	0/102 (0.00%)
Haematoma † 1	0/225 (0.00%)	0/103 (0.00%)	1/102 (0.98%)
1 Term from vocabulary, 15.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	BI 695501 to BI 695501	Humira® to Humira®	Humira® to BI 695501
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	9/225 (4.00%)	6/103 (5.83%)	2/102 (1.96%)
Infections and infestations
Upper respiratory tract infection † 1	9/225 (4.00%)	6/103 (5.83%)	2/102 (1.96%)
1 Term from vocabulary, 15.0; † Indicates events were collected by systematic assessment

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.

Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.

Results Point of Contact

• Name/Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim
• Phone: 1-800-243-0127
• EMail: clintriage.rdg@boehringer-ingelheim.com

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

Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.

Kang J, Eudy-Byrne RJ, Mondick J, Knebel W, Jayadeva G, Liesenfeld KH. Population pharmacokinetics of adalimumab biosimilar adalimumab-adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity. Br J Clin Pharmacol. 2020 Nov;86(11):2274-2285. doi: 10.1111/bcp.14330. Epub 2020 Jun 11.

Cohen SB, Czeloth N, Lee E, Klimiuk PA, Peter N, Jayadeva G. Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext). Expert Opin Biol Ther. 2019 Oct;19(10):1097-1105. doi: 10.1080/14712598.2019.1645114. Epub 2019 Aug 6.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02640612
• Other Study ID Numbers: 1297.3; 2015-002634-41 ( EudraCT Number )
• First Submitted: December 18, 2015
• First Posted: December 29, 2015
• Results First Submitted: October 22, 2018
• Results First Posted: December 5, 2018
• Last Update Posted: December 5, 2018