A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01712178
• Collaborator: (none)
• Enrollment: 100
• Locations: 21
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

A study in Rheumatoid Arthritis (RA) patients to evaluate two formulations of adalimumab for pharmacodynamics, pharmacokinetics, and safety.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Biological: Adalimumab, current formulation; Biological: Adalimumab, new formulation	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of a New Adalimumab Formulation in Subjects With Active Rheumatoid Arthritis
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: New formulation of adalimumab 40 mg every other week New formulation adalimumab 40 mg every other week	Biological: Adalimumab, new formulation; New formulation adalimumab 40 mg every other week
Active Comparator: Current formulation adalimumab 40 mg every other week Current formulation adalimumab 40 mg every other week	Biological: Adalimumab, current formulation; Current formulation adalimumab 40 mg every other week; Other Names: Humira

Outcome Measures

Primary Outcome Measures

1. Serum Concentrations of Adalimumab at Weeks 12 and 24 [Measured at Weeks 12 and 24]

   Blood samples for adalimumab analysis were collected by venipuncture and serum concentrations of adalimumab were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method.

2. Mean Disease Activity Scores (DAS28) at Weeks 12 and 24 [Measured at Weeks 12 and 24]

   The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

Secondary Outcome Measures

1. Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24 [Measured at Weeks 12 and 24]

   American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Disability Index of the Health Assessment Questionnaire CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))

2. Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24 [Measured at Weeks 12 and 24]

   American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Disability Index of the Health Assessment Questionnaire CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))

3. Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24 [Measured at Weeks 12 and 24]

   The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.

4. Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24 [Measured at Weeks 12 and 24]

   The Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 (maximum disability) - 100 (no disability). The standard recall period is four weeks.

5. Percentage of Participants Positive for Anti-adalimumab Antibody [Measured through Week 24]

   Percentage of participants with anti-adalimumab antibody

6. Number of Participants With Adverse Events [From time of informed consent to 70 days following the last dose of study drug]

   An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. See the Reported Adverse Events Section for more details.

7. Mean Injection Site Pain on a Visual Analogue Scale (VAS) [Immediately after injections on Day 1]

   The Visual Analogue Scale (VAS) consisted of a horizontal 100 mm line, with 0 representing "no pain" and 100 representing "worst possible pain". Participants placed a mark on the line representing their current level of pain immediately after injections on Day 1 of the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female subject, 18 years or older who has a diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987-revised American College of Rheumatology (ACR)-classification criteria or the new American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) diagnostic criteria for RA 2010-classification criteria and has a disease duration for a minimum of 3 months.

• Subjects must be naïve to biologic therapy.

• Subject must meet the following criteria for the joint assessment: • At least 6 swollen joints out of 66 assessed. • At least 6 tender joints out of 68 assessed.

• Prior Disease Modifying Antirheumatic Drug (DMARD) therapy: a) Subjects not on methotrexate at baseline must remain without methotrexate throughout the study. Subjects on prior Methotrexate (MTX) must have discontinued at least 28 days prior to Week 0 (Day 1). b) Subjects on Disease Modifying Antirheumatic Drug (DMARD) therapy other than Methotrexate (MTX) (except prednisone/prednisolone less than or equal to 10 mg) must discontinue it for at least 28 days before the first dose of investigational product at Week 0 (Day 1).

• Female subjects are either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy), or are practicing at least 1 of the following methods of birth control throughout the study and for at least 150 days after the last dose of study drug: • Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD). • Hormonal contraceptives for 90 days prior to study drug administration. • Vasectomized partner(s).

• Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer subcutaneous (SC) injections.

• Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile, chest x-ray (CXR), and 12 lead electrocardiogram (ECG) performed during Screening.

• Subject has a negative Tuberculosis (TB) screening assessment (including a (Purified Protein Derivative (PPD) test or QuantiFERON-Tuberculosis (TB) Gold test or equivalent) and negative chest x-ray (Posterior-Anterior (PA) and lateral view) at Screening. If a subject has evidence of a latent Tuberculosis (TB) infection, the subject must initiate and complete a minimum of 2 weeks of anti-Tuberculosis (TB) therapy or have documented completion of a course of anti-Tuberculosis (TB) therapy prior to Baseline.

• Subjects must be willing to provide written consent and to comply with the requirements of this study protocol.

Exclusion Criteria:

• Subject has been treated with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks from Baseline visit. Inhaled corticosteroids for stable medical conditions are allowed. Oral of less than or equal to 10 mg/d prednisone equivalent are allowed.

• Subject has been treated with any investigational drug of a chemical or biological nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to Baseline Visit.

• Subject has a history of acute inflammatory joint disease of different origin other than Rheumatoid Arthritis (RA) (e.g., seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus, gouty arthritis, or any arthritis with onset prior to age 17 years).

• Known hypersensitivity to adalimumab or its excipients.

• Subject currently uses or plans to use anti-retroviral therapy at any time during the study.

• History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.

• History of invasive infection (e.g., listeriosis and histoplasmosis), human immunodeficiency syndrome (HIV).

• Chronic recurring infections or active Tuberculosis (TB).

• History of moderate to severe congestive heart failure (New York Heart Association (NYHA) class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.

• Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.

• Subject received any live vaccine within 3 months prior to study drug administration.

• Subject has a history of clinically significant hematologic (e.g., severe anemia, leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis, hepatitis).

• Positive pregnancy test at Screening or Baseline.

• Subject is considered by the investigator, for any reason, to be unsuitable candidate for the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 75073	Mesa	Arizona	United States	85202
2	Site Reference ID/Investigator# 75077	Hemet	California	United States	92543
3	Site Reference ID/Investigator# 75076	Wichita	Kansas	United States	67203
4	Site Reference ID/Investigator# 75075	Clifton	New Jersey	United States	07012
5	Site Reference ID/Investigator# 83133	Philadelphia	Pennsylvania	United States	19152
6	Site Reference ID/Investigator# 75074	Charleston	South Carolina	United States	29406
7	Site Reference ID/Investigator# 75100	Brussels		Belgium	1200
8	Site Reference ID/Investigator# 75101	Liege		Belgium	4000
9	Site Reference ID/Investigator# 75104	Brno		Czech Republic	638 00
10	Site Reference ID/Investigator# 76788	Prague 2		Czech Republic	128 50
11	Site Reference ID/Investigator# 75102	Uherske Hradiste		Czech Republic	686 01
12	Site Reference ID/Investigator# 75103	Zlin		Czech Republic	760 01
13	Site Reference ID/Investigator# 78014	Ratingen		Germany	40882
14	Site Reference ID/Investigator# 75079	Caguas		Puerto Rico	00725
15	Site Reference ID/Investigator# 75078	Vega Baja		Puerto Rico	00693
16	Site Reference ID/Investigator# 76787	Bucharest		Romania	020475
17	Site Reference ID/Investigator# 75978	Cluj-Napoca		Romania	400006
18	Site Reference ID/Investigator# 76433	Ploiesti		Romania	100337
19	Site Reference ID/Investigator# 76934	Banska Bystrica		Slovakia	97405
20	Site Reference ID/Investigator# 76935	Senica		Slovakia	905 01
21	Site Reference ID/Investigator# 76682	Zilina		Slovakia	010 01

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Andy Payne, PhD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US prescribing information for approved uses.

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01712178
• Other Study ID Numbers: M13-390; 2012-000535-36
• First Posted: Oct 23, 2012
• Last Update Posted: Jun 11, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by AbbVie (prior sponsor, Abbott): Pharmacodynamic,Pharmacokinetic
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Adalimumab

Study Results

Participant Flow

Arm/Group Title	New Formulation of Adalimumab 40 mg Every Other Week	Current Formulation Adalimumab 40 mg Every Other Week
Arm/Group Description	New formulation adalimumab 40 mg every other week Adalimumab, new formulation: New formulation adalimumab 40 mg every other week	Current formulation adalimumab 40 mg every other week Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week
Period Title: Overall Study
STARTED	50	50
COMPLETED	49	47
NOT COMPLETED	1	3

Baseline Characteristics

Arm/Group Title	New Formulation of Adalimumab 40 mg Every Other Week	Current Formulation Adalimumab 40 mg Every Other Week	Total
Arm/Group Description	New formulation adalimumab 40 mg every other week Adalimumab, new formulation: New formulation adalimumab 40 mg every other week	Current formulation adalimumab 40 mg every other week Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week	Total of all reporting groups
Overall Participants	50	50	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.5 (11.0)	53.0 (12.3)	54.3 (11.6)
Sex: Female, Male (Count of Participants)
Female	41 82%	41 82%	82 82%
Male	9 18%	9 18%	18 18%

Outcome Measures

1. Primary Outcome

Title	Serum Concentrations of Adalimumab at Weeks 12 and 24
Description	Blood samples for adalimumab analysis were collected by venipuncture and serum concentrations of adalimumab were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method.
Time Frame	Measured at Weeks 12 and 24

Outcome Measure Data

Analysis Population Description

Data from participants receiving the new formulation of adalimumab were analyzed for 46 and 47 participants, respectively, at weeks 12 and 24. Data for the participants receiving the current formulation of adalimumab were analyzed for 43 participants at week 12 and 41 participants at week 24.

Arm/Group Title	New Formulation of Adalimumab 40 mg Every Other Week	Current Formulation Adalimumab 40 mg Every Other Week
Arm/Group Description	New formulation adalimumab 40 mg every other week Adalimumab, new formulation: New formulation adalimumab 40 mg every other week	Current formulation adalimumab 40 mg every other week Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week
Measure Participants	47	43
Week 12: n= 46 (new), n=43 (current)	5.72 (4.49)	6.23 (4.29)
Week 24: n= 47 (new), n=41 (current)	5.95 (5.13)	6.17 (4.50)

2. Primary Outcome

Title	Mean Disease Activity Scores (DAS28) at Weeks 12 and 24
Description	The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Time Frame	Measured at Weeks 12 and 24

Outcome Measure Data

Analysis Population Description

All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.

Arm/Group Title	New Formulation of Adalimumab 40 mg Every Other Week	Current Formulation Adalimumab 40 mg Every Other Week
Arm/Group Description	New formulation adalimumab 40 mg every other week Adalimumab, new formulation: New formulation adalimumab 40 mg every other week	Current formulation adalimumab 40 mg every other week Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week
Measure Participants	50	50
Week 12	3.78 (0.147)	3.82 (0.148)
Week 24	3.54 (0.152)	3.46 (0.153)

3. Secondary Outcome

Title	Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24
Description	American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Disability Index of the Health Assessment Questionnaire CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Time Frame	Measured at Weeks 12 and 24

Outcome Measure Data

Analysis Population Description

All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.

Arm/Group Title	New Formulation of Adalimumab 40 mg Every Other Week	Current Formulation Adalimumab 40 mg Every Other Week
Arm/Group Description	New formulation adalimumab 40 mg every other week Adalimumab, new formulation: New formulation adalimumab 40 mg every other week	Current formulation adalimumab 40 mg every other week Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week
Measure Participants	50	50
Week 12	62.0 124%	68.0 136%
Week 24	68.0 136%	68.0 136%

4. Secondary Outcome

Title	Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24
Description	American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Disability Index of the Health Assessment Questionnaire CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Time Frame	Measured at Weeks 12 and 24

Outcome Measure Data

Analysis Population Description

All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.

Arm/Group Title	New Formulation of Adalimumab 40 mg Every Other Week	Current Formulation Adalimumab 40 mg Every Other Week
Arm/Group Description	New formulation adalimumab 40 mg every other week Adalimumab, new formulation: New formulation adalimumab 40 mg every other week	Current formulation adalimumab 40 mg every other week Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week
Measure Participants	50	50
Week 12	36.0 72%	40.0 80%
Week 24	48.0 96%	50.0 100%

5. Secondary Outcome

Title	Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24
Description	The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.
Time Frame	Measured at Weeks 12 and 24

Outcome Measure Data

Analysis Population Description

All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.

Arm/Group Title	New Formulation of Adalimumab 40 mg Every Other Week	Current Formulation Adalimumab 40 mg Every Other Week
Arm/Group Description	New formulation adalimumab 40 mg every other week Adalimumab, new formulation: New formulation adalimumab 40 mg every other week	Current formulation adalimumab 40 mg every other week Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week
Measure Participants	50	50
Week 12	1.10 (0.075)	1.02 (0.076)
Week 24	1.01 (0.082)	0.97 (0.083)

6. Secondary Outcome

Title	Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24
Description	The Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 (maximum disability) - 100 (no disability). The standard recall period is four weeks.
Time Frame	Measured at Weeks 12 and 24

Outcome Measure Data

Analysis Population Description

All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.

Arm/Group Title	New Formulation of Adalimumab 40 mg Every Other Week	Current Formulation Adalimumab 40 mg Every Other Week
Arm/Group Description	New formulation adalimumab 40 mg every other week Adalimumab, new formulation: New formulation adalimumab 40 mg every other week	Current formulation adalimumab 40 mg every other week Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week
Measure Participants	50	49
PCS score- Week 12	38.88 (0.957)	39.08 (0.974)
PCS score- Week 24	39.38 (1.044)	39.94 (1.022)
MCS score- Week 12	44.78 (1.172)	42.78 (1.192)
MCS score- Week 24	43.16 (1.246)	45.46 (1.267)

7. Secondary Outcome

Title	Percentage of Participants Positive for Anti-adalimumab Antibody
Description	Percentage of participants with anti-adalimumab antibody
Time Frame	Measured through Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	New Formulation of Adalimumab 40 mg Every Other Week	Current Formulation Adalimumab 40 mg Every Other Week
Arm/Group Description	New formulation adalimumab 40 mg every other week Adalimumab, new formulation: New formulation adalimumab 40 mg every other week	Current formulation adalimumab 40 mg every other week Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week
Measure Participants	50	50
Number [Percentage of participants]	14 28%	16 32%

8. Secondary Outcome

Title	Number of Participants With Adverse Events
Description	An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. See the Reported Adverse Events Section for more details.
Time Frame	From time of informed consent to 70 days following the last dose of study drug

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	New Formulation of Adalimumab 40 mg Every Other Week	Current Formulation Adalimumab 40 mg Every Other Week
Arm/Group Description	New formulation adalimumab 40 mg every other week Adalimumab, new formulation: New formulation adalimumab 40 mg every other week	Current formulation adalimumab 40 mg every other week Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week
Measure Participants	50	50
Number [participants]	31 62%	34 68%

9. Secondary Outcome

Title	Mean Injection Site Pain on a Visual Analogue Scale (VAS)
Description	The Visual Analogue Scale (VAS) consisted of a horizontal 100 mm line, with 0 representing "no pain" and 100 representing "worst possible pain". Participants placed a mark on the line representing their current level of pain immediately after injections on Day 1 of the study.
Time Frame	Immediately after injections on Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	New Formulation of Adalimumab 40 mg Every Other Week	Current Formulation Adalimumab 40 mg Every Other Week
Arm/Group Description	New formulation adalimumab 40 mg every other week Adalimumab, new formulation: New formulation adalimumab 40 mg every other week	Current formulation adalimumab 40 mg every other week Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week
Measure Participants	49	50
Mean (Standard Deviation) [Millimeters]	14.4 (22.6)	35.9 (29.2)

Adverse Events

Time Frame	Adverse events were collected from the time of study drug administration until 70 days following the last dose. Serious adverse events were collected from the time the participant signed the informed consent.
Arm/Group Title	New Formulation of Adalimumab 40 mg Every Other Week		Current Formulation Adalimumab 40 mg Every Other Week
Arm/Group Description
All Cause Mortality
	New Formulation of Adalimumab 40 mg Every Other Week		Current Formulation Adalimumab 40 mg Every Other Week
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	New Formulation of Adalimumab 40 mg Every Other Week		Current Formulation Adalimumab 40 mg Every Other Week
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		2/50 (4%)
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE	0/50 (0%)		1/50 (2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TRANSITIONAL CELL CARCINOMA	0/50 (0%)		1/50 (2%)
Other (Not Including Serious) Adverse Events
	New Formulation of Adalimumab 40 mg Every Other Week		Current Formulation Adalimumab 40 mg Every Other Week
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/50 (46%)		16/50 (32%)
Gastrointestinal disorders
DYSPEPSIA	3/50 (6%)		1/50 (2%)
NAUSEA	4/50 (8%)		0/50 (0%)
General disorders
INJECTION SITE REACTION	3/50 (6%)		0/50 (0%)
Infections and infestations
CYSTITIS	4/50 (8%)		2/50 (4%)
NASOPHARYNGITIS	5/50 (10%)		6/50 (12%)
SINUSITIS	3/50 (6%)		1/50 (2%)
UPPER RESPIRATORY TRACT INFECTION	4/50 (8%)		4/50 (8%)
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS	3/50 (6%)		4/50 (8%)
Respiratory, thoracic and mediastinal disorders
COUGH	3/50 (6%)		1/50 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.