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A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis

Primary Purpose

Arthritis, Rheumatoid

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CP-195,543

celecoxib

Methotrexate

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid

Eligibility Criteria

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

Inclusion Criteria:

A diagnosis of RA based upon the American college of Rheumatology 1987 revised criteria
Active disease at Screening
Stable dose of methotrexate between 10-25 mg/week oral or parenteral

Exclusion Criteria:

A diagnosis of any other inflammatory or secondary, noninflammatory arthritis that, in the opinion of the Investigator, would interfere with disease activity assessments
A history of hypersensitivity or allergic type reactions to cyclooxygenase inhibitors, opiates, aspirin or sulfonamides

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Experimental

Arm Label

Celecoxib

Methotrexate

CP-195,543

Arm Description

Celecoxib with placebo therapy.

Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.

CP-195,543 and Celecoxib dual therapy.

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 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; 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 at Week 1, 2, 4 and 8

ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; 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).

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

ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; 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 Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

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

ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; 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 Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12

Participants were assessed for tender/painful joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.

Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12

Participants were assessed for swollen joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.

Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12

Patient's assessment of arthritis pain was assessed using a 100 millimeter (mm) visual analogue scale (VAS) with range: 0 = no pain to 100 = worst possible pain.

Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12

Patient's global assessment of arthritic condition assessed all the ways participants' illness and health conditions affect them at the time of assessment. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).

Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12

Investigator assessed overall appearance of arthritis at the time of the visit. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12

Health Assessment Questionnaire-Disability Index (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 C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12

DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP. It was calculated as DAS28-3 (CRP) = 1.15 + 1.10 * ([0.56 * square root of TJC] + [0.28 * square root of SJC] + [0.36 * natural logarithm of {CRP+1}]). 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 DAS28-3 (CRP) <2.6 = remission.

Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12

Duration of morning stiffness was defined as the time elapsed between the time participant woke up and was able to resume normal activities without stiffness in hours (duration was recorded in hours to the nearest quarter. For those participants with unrelenting stiffness, duration was recorded as 24 hours).

Number of Participants Who Withdrew From Study Due to Lack of Efficacy

Time to Withdrawal Due to Lack of Efficacy

Number of Participants With Clinical Laboratory Abnormalities

Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).

Full Information

NCT ID

NCT00424294

First Posted

January 18, 2007

Last Updated

September 10, 2014

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00424294

Brief Title

A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CP-195543 And Celecoxib Dual Therapy In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On Methotrexate

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Terminated

Why Stopped

See Detailed Description field

Study Start Date

June 2006 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis

Detailed Description

Trial enrollment was prematurely discontinued on December 3, 2007. The results of an interim efficacy and safety analysis demonstrated an overall poor tolerability profile and high discontinuation rate when dual therapy with CP-195543 and Celecoxib was administered. The decision to discontinue further enrollment in the trial was not based on any efficacy or serious safety concerns. Previously enrolled study participants continued in the study and the trial completed on February 27, 2008.

6. Conditions and Keywords

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

Arthritis, Rheumatoid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Celecoxib

Arm Type

Active Comparator

Arm Description

Celecoxib with placebo therapy.

Arm Title

Methotrexate

Arm Type

Other

Arm Description

Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.

Arm Title

CP-195,543

Arm Type

Experimental

Arm Description

CP-195,543 and Celecoxib dual therapy.

Intervention Type

Drug

Intervention Name(s)

CP-195,543

Intervention Description

CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.

Intervention Type

Drug

Intervention Name(s)

celecoxib

Intervention Description

Celecoxib is a nonsteroidal anit-inflammatory drug (NSAID) marketed worldwide (in the United States [US] as Celeberex) and approved for the relief of signs and symptoms of osteoarthritis.

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

Methotrexate is a folate analogue that, based on it efficacy and safety in RA, is commonly used as frontline DMARD treatment in patients with moderate to severe disease who do not respond to NSAIDs alone.

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 at Week 1, 2, 4 and 8

Description

Time Frame

Week 1, 2, 4, 8

Title

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

Description

Time Frame

Week 1, 2, 4, 8, 12

Title

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

Description

Time Frame

Week 1, 2, 4, 8, 12

Title

Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 1, 2, 4, 8, 12

Title

Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 1, 2, 4, 8, 12

Title

Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12

Description

Patient's assessment of arthritis pain was assessed using a 100 millimeter (mm) visual analogue scale (VAS) with range: 0 = no pain to 100 = worst possible pain.

Time Frame

Baseline, Week 1, 2, 4, 8, 12

Title

Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 1, 2, 4, 8, 12

Title

Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 1, 2, 4, 8, 12

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 1, 2, 4, 8, 12

Title

Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 1, 2, 4, 8, 12

Title

Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 1, 2, 4, 8, 12

Title

Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12

Description

Time Frame

Baseline, Week 1, 2, 4, 8, 12

Title

Number of Participants Who Withdrew From Study Due to Lack of Efficacy

Time Frame

Baseline up to Week 12

Title

Time to Withdrawal Due to Lack of Efficacy

Time Frame

Baseline up to Week 12

Title

Number of Participants With Clinical Laboratory Abnormalities

Description

Time Frame

Baseline up to Week 13

Other Pre-specified Outcome Measures:

Title

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Time Frame

Baseline up to 28 days after last dose

Title

Number of Adverse Events by Severity

Description

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.

Time Frame

Baseline up to 28 days after last dose

Title

Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91

Description

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated in sitting position.

Time Frame

Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91

Title

Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91

Time Frame

Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91

Title

Number of Participants With Abnormal Electrocardiogram (ECG)

Description

Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.

Time Frame

Baseline up to Week 12

Title

Number of Participants With Categorical Vital Signs Data

Description

Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 12 was reported.

Time Frame

Baseline, Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A diagnosis of RA based upon the American college of Rheumatology 1987 revised criteria Active disease at Screening Stable dose of methotrexate between 10-25 mg/week oral or parenteral Exclusion Criteria: A diagnosis of any other inflammatory or secondary, noninflammatory arthritis that, in the opinion of the Investigator, would interfere with disease activity assessments A history of hypersensitivity or allergic type reactions to cyclooxygenase inhibitors, opiates, aspirin or sulfonamides

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

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Pfizer Investigational Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

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

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Pfizer Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Pfizer Investigational Site

City

Dunedin

State/Province

Florida

ZIP/Postal Code

34698

Country

United States

Facility Name

Pfizer Investigational Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33334

Country

United States

Facility Name

Pfizer Investigational Site

City

Lake Mary

State/Province

Florida

ZIP/Postal Code

32746

Country

United States

Facility Name

Pfizer Investigational Site

City

Miramar

State/Province

Florida

ZIP/Postal Code

33025

Country

United States

Facility Name

Pfizer Investigational Site

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Pfizer Investigational Site

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

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

Port Richey

State/Province

Florida

ZIP/Postal Code

34668

Country

United States

Facility Name

Pfizer Investigational Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34233

Country

United States

Facility Name

Pfizer Investigational Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Pfizer Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614-7118

Country

United States

Facility Name

Pfizer Investigational Site

City

Venice

State/Province

Florida

ZIP/Postal Code

34292

Country

United States

Facility Name

Pfizer Investigational Site

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Pfizer Investigational Site

City

Moline

State/Province

Illinois

ZIP/Postal Code

61265

Country

United States

Facility Name

Pfizer Investigational Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Pfizer Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46250

Country

United States

Facility Name

Pfizer Investigational Site

City

Munster

State/Province

Indiana

ZIP/Postal Code

46321

Country

United States

Facility Name

Pfizer Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Pfizer Investigational Site

City

Covington

State/Province

Louisiana

ZIP/Postal Code

70433

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

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

Facility Name

Pfizer Investigational Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49009

Country

United States

Facility Name

Pfizer Investigational Site

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Facility Name

Pfizer Investigational Site

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Pfizer Investigational Site

City

Olean

State/Province

New York

ZIP/Postal Code

14760

Country

United States

Facility Name

Pfizer Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73139

Country

United States

Facility Name

Pfizer Investigational Site

City

Philladelphia

State/Province

Pennsylvania

ZIP/Postal Code

19118

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

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Pfizer Investigational Site

City

Killeen

State/Province

Texas

ZIP/Postal Code

76549

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

Pfizer Investigational Site

City

Ogden

State/Province

Utah

ZIP/Postal Code

84403

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7701005&StudyName=A%20Study%20Of%20CP-195543%20And%20Celecoxib%20Dual%20Therapy%20In%20Subjects%20With%20Rheumatoid%20Arthritis

Description

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A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis

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A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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