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Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Placebo
Adalimumab 80 mg
Adalimumab 40 mg
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Humira, methotrexate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Met ACR criteria for diagnosis of active rheumatoid arthritis (RA) and have had at both the Screening visit and Week 0 visit at least four swollen joints (out of 66 assessed) and at least six tender joints(out of 68 assessed)
  • Subjects must have failed prior treatment with one or more disease-modifying antirheumatic drugs (DMARDs)
  • DMARDs (other than methotrexate [MTX]) must have been discontinued for >= 28 days or at least 5 half-lives, whichever is greater, before the Week 0 visit
  • Traditional Chinese Medicines must have been discontinued for >= 28 days before the Week 0 visit
  • Subjects must have received at least three months of treatment with MTX (minimum 7.5 mg/week) and remained on a stable dose of MTX for >= 28 days prior to the Screening visit
  • Glucocorticoids equivalent to <= 10 mg of prednisone and prednisone equivalent must have remained unchanged for at least 28 days prior to the Week 0 visit
  • Must have been able and willing to give written informed consent and to comply with the requirements of this study protocol

Exclusion Criteria:

  • A history of, or current, acute inflammatory joint disease of different origin (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus, fibromyalgia or any arthritide with onset prior to age 16 years
  • Wheelchair-bound or bedridden
  • Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit
  • Intra-articular, intramuscular or intravenous administration of corticosteroids within 28 days prior to the Screening visit
  • Prior treatment with any TNF antagonist, including adalimumab
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant

Sites / Locations

  • Site Reference ID/Investigator# 6259
  • Site Reference ID/Investigator# 6266
  • Site Reference ID/Investigator# 6241
  • Site Reference ID/Investigator# 6243
  • Site Reference ID/Investigator# 6247
  • Site Reference ID/Investigator# 6262
  • Site Reference ID/Investigator# 6248
  • Site Reference ID/Investigator# 6250
  • Site Reference ID/Investigator# 6828
  • Site Reference ID/Investigator# 6333
  • Site Reference ID/Investigator# 6264

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Adalimumab 80 mg

Adalimumab 40 mg

Arm Description

Placebo administered subcutaneously every other week

Adalimumab 80 mg administered subcutaneously every other week

Adalimumab 40 mg administered subcutaneously every other week

Outcomes

Primary Outcome Measures

Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period
American College of Rheumatology (ACR) criteria improvement consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-Blind period.

Secondary Outcome Measures

Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind Period
American College of Rheumatology (ACR) criteria improvement consisting of 50% or 70% (ACR50/70) reduction in tender or swollen joint counts and 50% or 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-blind period.
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 50% (ACR50) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 70% (ACR70) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period
Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period.
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period.
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period.
Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period
Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state. Week 12 = end of Double-Blind period.
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Scores From Baseline to Week 12 of the Double-Blind Period
HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index = improvement in disease (0 = no difficulties). Week 12 = end of Double-Blind period.
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index indicates an improvement in disease (0 = no difficulties).
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 12 of the Double-Blind Period
SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period
SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period
SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.

Full Information

First Posted
October 1, 2007
Last Updated
April 7, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00538902
Brief Title
Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate
Official Title
A Multi-center Randomized, Phase 2/3, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Safety and Efficacy of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A study to assess the safety and efficacy of adalimumab administered as a subcutaneous injection in adult Chinese subjects with rheumatoid arthritis and treated with methotrexate
Detailed Description
This was a multi-center, Phase 2/3, randomized, double-blind (DB), parallel group, placebo controlled, safety and efficacy study in adult Chinese RA subjects. The duration of the study was approximately 116 weeks. This included a 4-week (28 days) Screening period, a 12-week Double-Blind (DB) period, a 90-week Open-Label (OL) Period, and a 10-week (70 days) Follow-up period. The 70-day Safety Follow-up period was initiated after the last dose of study medication. During the DB period, 302 Chinese subjects with RA and concomitantly treated with MTX were enrolled at 11 clinical sites located throughout China. Subjects were randomly assigned to one of the three treatment groups in a 2:2:1 ratio: 80 mg adalimumab, 40 mg adalimumab, or placebo. From Week 0 to Week 10, subjects received blinded study drug. Subjects who successfully participated and completed Week 12 of the DB portion of the study participated in the OL period. All subjects in the OL period received adalimumab 40 mg. Throughout the study, the study drug was administered subcutaneously (SC) every other week (eow). Subjects that completed the Week 24 visit, prior to the approval of Protocol Amendment 1, had 70 days from the last dose of study drug to re-enter the study. The Investigator confirmed that the subject did not develop any of the exclusion criteria and completed the procedures defined by the OL Screening visit. Results through Week 24 of this study were presented in the regulatory dossier for the marketing authorization application of Humira in China, fulfilling the requirement for clinical data in Chinese patients. However, in order to continue to provide treatment to patients who responded well to adalimumab, subjects had the option to continue in the OL extension of this study until Week 92.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Humira, methotrexate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered subcutaneously every other week
Arm Title
Adalimumab 80 mg
Arm Type
Experimental
Arm Description
Adalimumab 80 mg administered subcutaneously every other week
Arm Title
Adalimumab 40 mg
Arm Type
Experimental
Arm Description
Adalimumab 40 mg administered subcutaneously every other week
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
Intervention Type
Biological
Intervention Name(s)
Adalimumab 80 mg
Other Intervention Name(s)
Humira
Intervention Description
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
Intervention Type
Biological
Intervention Name(s)
Adalimumab 40 mg
Other Intervention Name(s)
Humira
Intervention Description
Adalimumab 40 mg administered subcutaneously every other week for 104 weeks
Primary Outcome Measure Information:
Title
Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period
Description
American College of Rheumatology (ACR) criteria improvement consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-Blind period.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind Period
Description
American College of Rheumatology (ACR) criteria improvement consisting of 50% or 70% (ACR50/70) reduction in tender or swollen joint counts and 50% or 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-blind period.
Time Frame
Week 12
Title
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
Description
American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time Frame
Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Title
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
Description
American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 50% (ACR50) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time Frame
Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Title
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
Description
American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 70% (ACR70) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time Frame
Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Title
Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period
Description
Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period.
Time Frame
Baseline, Week 12
Title
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Description
Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period.
Time Frame
Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Title
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Description
Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period.
Time Frame
Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Title
Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period
Description
Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state. Week 12 = end of Double-Blind period.
Time Frame
Baseline, Week 12
Title
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Description
Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.
Time Frame
Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Title
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Description
Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.
Time Frame
Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Title
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Description
Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.
Time Frame
Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Title
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Scores From Baseline to Week 12 of the Double-Blind Period
Description
HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index = improvement in disease (0 = no difficulties). Week 12 = end of Double-Blind period.
Time Frame
Baseline, Week 12
Title
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
Description
HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index indicates an improvement in disease (0 = no difficulties).
Time Frame
Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Title
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 12 of the Double-Blind Period
Description
SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.
Time Frame
Baseline, Week 12
Title
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period
Description
SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.
Time Frame
Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92
Title
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period
Description
SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.
Time Frame
Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Met ACR criteria for diagnosis of active rheumatoid arthritis (RA) and have had at both the Screening visit and Week 0 visit at least four swollen joints (out of 66 assessed) and at least six tender joints(out of 68 assessed) Subjects must have failed prior treatment with one or more disease-modifying antirheumatic drugs (DMARDs) DMARDs (other than methotrexate [MTX]) must have been discontinued for >= 28 days or at least 5 half-lives, whichever is greater, before the Week 0 visit Traditional Chinese Medicines must have been discontinued for >= 28 days before the Week 0 visit Subjects must have received at least three months of treatment with MTX (minimum 7.5 mg/week) and remained on a stable dose of MTX for >= 28 days prior to the Screening visit Glucocorticoids equivalent to <= 10 mg of prednisone and prednisone equivalent must have remained unchanged for at least 28 days prior to the Week 0 visit Must have been able and willing to give written informed consent and to comply with the requirements of this study protocol Exclusion Criteria: A history of, or current, acute inflammatory joint disease of different origin (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus, fibromyalgia or any arthritide with onset prior to age 16 years Wheelchair-bound or bedridden Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit Intra-articular, intramuscular or intravenous administration of corticosteroids within 28 days prior to the Screening visit Prior treatment with any TNF antagonist, including adalimumab Subject considered by the investigator, for any reason, to be an unsuitable candidate Female subject who is pregnant or breast-feeding or considering becoming pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Redden, MD, PhD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 6259
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Site Reference ID/Investigator# 6266
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Site Reference ID/Investigator# 6241
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Site Reference ID/Investigator# 6243
City
Guangzhou
ZIP/Postal Code
510260
Country
China
Facility Name
Site Reference ID/Investigator# 6247
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Facility Name
Site Reference ID/Investigator# 6262
City
Harbin
ZIP/Postal Code
150001
Country
China
Facility Name
Site Reference ID/Investigator# 6248
City
Hepingjiebeikou
ZIP/Postal Code
100029
Country
China
Facility Name
Site Reference ID/Investigator# 6250
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Site Reference ID/Investigator# 6828
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Site Reference ID/Investigator# 6333
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Site Reference ID/Investigator# 6264
City
Xi'an
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27338778
Citation
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
Results Reference
derived

Learn more about this trial

Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

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