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A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

Primary Purpose

Arthritis, Rheumatoid

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Adalimumab

CP-690-550

CP-690,550

Placebo

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Janus Kinase 3 Clinical Trial

Eligibility Criteria

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

Inclusion Criteria:

Subjects must have active rheumatoid arthritis
Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)
Subjects must not be currently taking any DMARD other than an antimalarial

Exclusion Criteria:

Subjects who discontinued any previous TNF inhibitor therapy for either lack of benefit or safety.
Subjects who previously received adalimumab (Humira®) therapy for any reason.
Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

ACR20 response: greater than or equal to (>=) 20 % improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

Secondary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

ACR20 response: 20% improvement in TJC; >=20% improvement in SJC; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response

ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response

ACR90 response: >= 90% improvement in TJC or SJC and 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve

ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. Area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.

Tender Joint Count (TJC)

Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.

Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET

Swollen Joint Counts (SJC)

Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.

Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24

Patient Assessment of Arthritis Pain

Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Patient Global Assessment (PtGA) of Arthritis Pain

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Physician Global Assessment (PGA) of Arthritis

Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

C-Reactive Protein (CRP)

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Health Assessment Questionnaire-Disability Index (HAQ-DI)

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])

DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.

Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission.

Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])

DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.

Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET

DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR [mm/hour] and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.

Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR)

Disease improvement was classified as good, moderate, and none based on improvement in DAS28-4 (ESR) from baseline and present DAS28-4 (ESR) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.

Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP)

CRP value less than or equal to upper limit of normal (ULN) implied disease remission (ULN=4.9 mg/L).

Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)

DAS28-3 (CRP) defined remission was classified as a score of <2.6.

36-Item Short-Form Health Survey (SF-36)

SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET

Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Full Information

NCT ID

NCT00550446

First Posted

October 25, 2007

Last Updated

November 29, 2012

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00550446

Brief Title

A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

Official Title

A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

Keywords

Janus Kinase 3 Clinical Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

386 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Adalimumab

Intervention Description

40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.

Intervention Type

Drug

Intervention Name(s)

CP-690-550

Intervention Description

15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)

Intervention Type

Drug

Intervention Name(s)

CP-690-550

Intervention Description

10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)

Intervention Type

Drug

Intervention Name(s)

CP-690-550

Intervention Description

5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

Description

Time Frame

Week 2, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET)

Title

Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response

Description

Time Frame

Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Title

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

Description

Time Frame

Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Title

Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response

Description

Time Frame

Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Title

Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve

Description

Time Frame

Baseline up to Week 2, 4, 6, 8, 10, 12

Title

Tender Joint Count (TJC)

Description

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Title

Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET

Description

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Title

Swollen Joint Counts (SJC)

Description

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Title

Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24

Description

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Title

Patient Assessment of Arthritis Pain

Description

Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Title

Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Description

Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Title

Patient Global Assessment (PtGA) of Arthritis Pain

Description

Time Frame

Baseline, 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Title

Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Description

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Title

Physician Global Assessment (PGA) of Arthritis

Description

Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Title

Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Description

Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Title

C-Reactive Protein (CRP)

Description

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Title

Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Description

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Title

Health Assessment Questionnaire-Disability Index (HAQ-DI)

Description

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Description

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Title

Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])

Description

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

Title

Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Description

DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission.

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

Title

Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])

Description

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

Title

Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET

Description

Time Frame

Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Title

Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR)

Description

Time Frame

Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Title

Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP)

Description

CRP value less than or equal to upper limit of normal (ULN) implied disease remission (ULN=4.9 mg/L).

Time Frame

Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

Title

Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)

Description

DAS28-3 (CRP) defined remission was classified as a score of <2.6.

Time Frame

Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

Title

36-Item Short-Form Health Survey (SF-36)

Description

Time Frame

Baseline, Week 12, 24/ ET

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET

Description

Time Frame

Baseline, Week 12, 24/ ET

Title

Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score

Description

Time Frame

Baseline, Week 12, 24/ ET

Title

Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET

Description

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Time Frame

Baseline, Week 12, 24/ ET

Other Pre-specified Outcome Measures:

Title

Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels

Description

Blood samples for immunoglobulin assessments were obtained to determine IgG, IgM, and IgA levels in serum.

Time Frame

Baseline, Week 24/ ET

Title

Change From Baseline in Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels at Week 24

Description

Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG, IgM, and IgA levels.

Time Frame

Baseline, Week 24/ ET

Title

Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers

Description

The following biomarkers were assessed: Cluster of Differentiation 3 (CD3), CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.

Time Frame

Baseline, Week 24/ ET

Title

Change From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24

Description

The following biomarkers were assessed: CD3, CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.

Time Frame

Baseline, Week 24/ ET

Title

Medical Outcome Study- Sleep Scale (MOS-SS)

Description

Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.

Time Frame

Baseline, Week 2, 12, 24/ ET

Title

Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET

Description

Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (A SOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.

Time Frame

Baseline, Week 2, 12, 24/ ET

Title

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale

Description

FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.

Time Frame

Baseline, Week 2, 12, 24/ ET

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET

Description

Time Frame

Baseline, Week 2, 12, 24/ ET

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must have active rheumatoid arthritis Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD) Subjects must not be currently taking any DMARD other than an antimalarial Exclusion Criteria: Subjects who discontinued any previous TNF inhibitor therapy for either lack of benefit or safety. Subjects who previously received adalimumab (Humira®) therapy for any reason. Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85208

Country

United States

Facility Name

Pfizer Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Pfizer Investigational Site

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Pfizer Investigational Site

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Pfizer Investigational Site

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Pfizer Investigational Site

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Facility Name

Pfizer Investigational Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Pfizer Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Pfizer Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Pfizer Investigational Site

City

Morton Grove

State/Province

Illinois

ZIP/Postal Code

60053

Country

United States

Facility Name

Pfizer Investigational Site

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61107

Country

United States

Facility Name

Pfizer Investigational Site

City

Cedar Rapids

State/Province

Iowa

ZIP/Postal Code

52401-2112

Country

United States

Facility Name

Pfizer Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67203

Country

United States

Facility Name

Pfizer Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67208

Country

United States

Facility Name

Pfizer Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70115

Country

United States

Facility Name

Pfizer Investigational Site

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Pfizer Investigational Site

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

Pfizer Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45408

Country

United States

Facility Name

Pfizer Investigational Site

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Pfizer Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909-1600

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Pfizer Investigational Site

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Pfizer Investigational Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Sao Paulo

State/Province

ZIP/Postal Code

01323-903

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Sofia 1606

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1709

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Santiago

State/Province

ZIP/Postal Code

8331030

Country

Chile

Facility Name

Pfizer Investigational Site

City

Santiago

State/Province

ZIP/Postal Code

8360156

Country

Chile

Facility Name

Pfizer Investigational Site

City

Providencia

State/Province

Santiago, RM

ZIP/Postal Code

7530206

Country

Chile

Facility Name

Pfizer Investigational Site

City

Split

ZIP/Postal Code

21000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Brno

ZIP/Postal Code

656 91

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Praha 11 - Chodov

ZIP/Postal Code

148 00

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Praha 2

ZIP/Postal Code

128 50

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Praha 4

ZIP/Postal Code

140 59

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Zlin

ZIP/Postal Code

760 01

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Dresden

ZIP/Postal Code

01067

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hildesheim

ZIP/Postal Code

31134

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Pfizer Investigational Site

City

Goudi

State/Province

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Pfizer Investigational Site

City

Thessaloniki

ZIP/Postal Code

54 636

Country

Greece

Facility Name

Pfizer Investigational Site

City

Szolnok

ZIP/Postal Code

H-5000

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

Pfizer Investigational Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

133-792

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Mexico

State/Province

D.f.

ZIP/Postal Code

06100

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Metepec

State/Province

Estado de Mexico

ZIP/Postal Code

52140

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44650

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Cuernavaca

State/Province

Morelos

ZIP/Postal Code

62270

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Bucuresti

ZIP/Postal Code

011172

Country

Romania

Facility Name

Pfizer Investigational Site

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

Pfizer Investigational Site

City

Iasi

ZIP/Postal Code

700661

Country

Romania

Facility Name

Pfizer Investigational Site

City

Piestany

ZIP/Postal Code

921 12

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Zilina

ZIP/Postal Code

012 07

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Kharkiv

ZIP/Postal Code

61000

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Kyiv

ZIP/Postal Code

04114

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Lviv

ZIP/Postal Code

79011

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Vinnitsa

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Zaporizhzhia

ZIP/Postal Code

69118

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

34870800

Citation

Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

Results Reference

derived

PubMed Identifier

33127856

Citation

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.

Results Reference

derived

PubMed Identifier

32816215

Citation

Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

Results Reference

derived

PubMed Identifier

31512746

Citation

Suzuki M, Shoji S, Miyoshi S, Krishnaswami S. Model-Based Comparison of Dose-Response Profiles of Tofacitinib in Japanese Versus Western Rheumatoid Arthritis Patients. J Clin Pharmacol. 2020 Feb;60(2):198-208. doi: 10.1002/jcph.1514. Epub 2019 Sep 12.

Results Reference

derived

PubMed Identifier

28941219

Citation

Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.

Results Reference

derived

PubMed Identifier

28143815

Citation

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

Results Reference

derived

PubMed Identifier

27156561

Citation

Wallenstein GV, Kanik KS, Wilkinson B, Cohen S, Cutolo M, Fleischmann RM, Genovese MC, Gomez Reino J, Gruben D, Kremer J, Krishnaswami S, Lee EB, Pascual-Ramos V, Strand V, Zwillich SH. Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials. Clin Exp Rheumatol. 2016 May-Jun;34(3):430-42. Epub 2016 Apr 28.

Results Reference

derived

PubMed Identifier

26275429

Citation

Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14. Erratum In: Ann Rheum Dis. 2017 Mar;76(3):611.

Results Reference

derived

PubMed Identifier

25047021

Citation

Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.

Results Reference

derived

PubMed Identifier

21952978

Citation

Fleischmann R, Cutolo M, Genovese MC, Lee EB, Kanik KS, Sadis S, Connell CA, Gruben D, Krishnaswami S, Wallenstein G, Wilkinson BE, Zwillich SH. Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. Arthritis Rheum. 2012 Mar;64(3):617-29. doi: 10.1002/art.33383.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921035&StudyName=A%20Phase%202%20Study%20For%20Patients%20With%20A%20Physician%27s%20Diagnosis%20Of%20Rheumatoid%20Arthritis%20%20

Description

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Learn more about this trial

A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

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A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

Arthritis, Rheumatoid

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial