Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00603512
First received: January 17, 2008
Last updated: December 16, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment with active rheumatoid arthritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis, Rheumatoid |
Drug: Placebo Drug: CP-690,550 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Confirm Dose Responsiveness Following 12 Weeks of the Administration of CP-690,550 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate Alone |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]ACR20 response: greater than or equal to (>=) 20 percent (%) 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 [ Time Frame: Week 1, 2, 4, 8 ] [ Designated as safety issue: No ]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 [ Time Frame: Week 1, 2, 4, 8, 12/End of Treatment (EOT) ] [ Designated as safety issue: No ]ACR50 response: >= 50% improvement in tender or swollen joint counts 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 [ Time Frame: Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]ACR70 response: >= 70% improvement in tender or swollen joint counts 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 [ Time Frame: Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]ACR90 response: >= 90% improvement in tender or swollen joint counts 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.
- Tender Joint Count (TJC) [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]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 (TJC) at Week 1, 2, 4, 8 and 12/EOT [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]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. A negative value in change from baseline indicates an improvement.
- Swollen Joint Count (SJC) [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]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 (SJC) at Week 1, 2, 4, 8 and 12/EOT [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]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. A negative value in change from baseline indicates an improvement.
- Patient Assessment of Arthritis Pain [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 = no pain and 100 = most severe pain.
- Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 = no pain and 100 = most severe pain.
- Patient Global Assessment (PtGA) of Arthritis [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]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 = very well and 100 = very poorly.
- Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]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 = very well and 100 = very poorly.
- Physician Global Assessment (PGA) of Arthritis [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.
- Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.
- Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]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 1, 2, 4, 8 and 12/EOT [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]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.
- C-Reactive Protein (CRP) [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]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 1, 2, 4, 8 and 12/EOT [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]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.
- Numeric Index of American College of Rheumatology Response (ACR-n) [ Time Frame: Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]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 Numeric Index of American College of Rheumatology Response (ACR-n) Curve [ Time Frame: Baseline up to Week 12 ] [ Designated as safety issue: No ]ACR-n = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of 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. The AUC for ACR-n is measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute AUC.
- Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint 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, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
- Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) [ Time Frame: Baseline, Week 1, 2, 4, 8, 12/EOT ] [ Designated as safety issue: No ]DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (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) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.
- 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Baseline, Week 12/EOT ] [ Designated as safety issue: No ]SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
- Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [ Time Frame: Baseline, Week 12/EOT ] [ Designated as safety issue: No ]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, selfcare, 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.
- Medical Outcome Study- Sleep Scale (MOS-SS) [ Time Frame: Baseline, Week 2, 12/EOT ] [ Designated as safety issue: No ]Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales:sleep disturbance(SD),snoring(Sno),awakened short of breath(ASOB),sleep adequacy(Ade),somnolence(Som)(range:0-100);sleep quantity(Qua)(range:0-24),optimal(Opt) sleep(yes:1,no:0),9 item index measures of sleep disturbance provide composite scores:sleep problem summary(SPS),overall SP(OSP).Except Ade,Opt,Qua,higher scores=more impairment.Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.
- Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale [ Time Frame: Baseline, Week 2, 12/EOT ] [ Designated as safety issue: No ]FACIT-F 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.
| Enrollment: | 140 |
| Study Start Date: | January 2008 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: CP-690,550, 0mg |
Drug: Placebo
0 mg BID, 3 blinded tablets administered BID for 12 weeks
|
| Experimental: CP-690,550, 10mg |
Drug: CP-690,550
10 mg BID, 3 blinded tablets administered BID for 12 weeks
|
| Experimental: CP-690,550, 1mg |
Drug: CP-690,550
1 mg BID, 3 blinded tablets administered BID for 12 weeks
|
| Experimental: CP-690,550, 3mg |
Drug: CP-690,550
3 mg BID, 3 blinded tablets administered BID for 12 weeks
|
| Experimental: CP-690,550, 5mg |
Drug: CP-690,550
5 mg BID, 3 blinded tablets administered BID for 12 weeks
|
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Active rheumatoid arthritis
- Inadequate response to stably dosed methotrexate
Exclusion Criteria:
- Current therapy with any DMARD or biologic other than methotrexate
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603512
Locations
| Japan | |
| Pfizer Investigational Site | |
| Hitachi-shi, Ibaraki, Japan | |
| Pfizer Investigational Site | |
| Sagamihara, Kanagawa, Japan | |
| Pfizer Investigational Site | |
| Yahatanishi-ku, Kitakyusyu, Japan | |
| Pfizer Investigational Site | |
| Koushi, Kumamoto, Japan | |
| Pfizer Investigational Site | |
| Sendai, Miyagi, Japan | |
| Pfizer Investigational Site | |
| Kawachinagano, Osaka, Japan | |
| Pfizer Investigational Site | |
| Kawagoe-shi, Saitama, Japan | |
| Pfizer Investigational Site | |
| Kitamoto, Saitama, Japan | |
| Pfizer Investigational Site | |
| Bunkyo-k, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Bunkyo-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Chiyoda-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Koto-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Meguro-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Musashimurayama-shi, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Shinjyuku-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Chiba, Japan | |
| Pfizer Investigational Site | |
| Fukuoka, Japan | |
| Pfizer Investigational Site | |
| Niigata, Japan | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00603512 History of Changes |
| Other Study ID Numbers: | A3921039 |
| Study First Received: | January 17, 2008 |
| Results First Received: | November 14, 2012 |
| Last Updated: | December 16, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Pfizer:
|
Phase II MTX add-on study in Japan |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013