Trial · NCT00424294
A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis
NCT00424294, Phase 2, Terminated, Pfizer; results first posted 2014-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis. Trials, record NCT00424294. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00424294
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis
- NCT number
- NCT00424294
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Arthritis, Rheumatoid
- Interventions
- CP-195,543, celecoxib, Methotrexate
- First posted
- 2007-01-19
- Last updated
- 2014-09-25
- Results first posted
- 2014-09-25
- Limitations and caveats
- The study was terminated early because it was determined that the dual therapy with CP-195543 and celecoxib had poor tolerability and a high discontinuation rate.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | 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 | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 | Week 1, 2, 4, 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). |
| Secondary | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 1, 2, 4, 8, 12 | 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). |
| Secondary | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 1, 2, 4, 8, 12 | 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). |
| Secondary | Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 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. |
| Secondary | Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 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. |
| Secondary | Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 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. |
| Secondary | Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 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). |
| Secondary | Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 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). |
| Secondary | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | Week 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using last observation carried forward (LOCF) method. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 | Week 1, 2, 4, 8 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | tender/painful joints | MEAN |
| SECONDARY | Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | swollen joints | MEAN |
| SECONDARY | Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | mm | MEAN |
| SECONDARY | Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12 | Baseline, Week 1, 2, 4, 8, 12 | FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,n signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used. | units on a scale | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group220
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | Placebo and Celecoxib | 31.43 | percentage of participants | ||
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 | CP-195543 and Celecoxib | 35.29 | percentage of participants | ||
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 | Placebo and Celecoxib | Week 1 | 31.43 | percentage of participants | |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 | CP-195543 and Celecoxib | Week 1 | 23.53 | percentage of participants | |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 | Placebo and Celecoxib | Week 2 | 28.57 | percentage of participants | |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 | CP-195543 and Celecoxib | Week 2 | 35.29 | percentage of participants | |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 | Placebo and Celecoxib | Week 4 | 28.57 | percentage of participants | |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 | CP-195543 and Celecoxib | Week 4 | 41.18 | percentage of participants | |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 | Placebo and Celecoxib | Week 8 | 25.71 | percentage of participants | |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8 | CP-195543 and Celecoxib | Week 8 | 38.24 | percentage of participants |
1 to 10 of 220Source ClinicalTrials.gov
See all 220 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo and Celecoxib | 36 | |
| Overall Study | STARTED | CP-195543 and Celecoxib | 34 | |
| Overall Study | Treated | Placebo and Celecoxib | 35 | |
| Overall Study | Treated | CP-195543 and Celecoxib | 34 | |
| Overall Study | COMPLETED | Placebo and Celecoxib | 28 | |
| Overall Study | COMPLETED | CP-195543 and Celecoxib | 19 | |
| Overall Study | NOT COMPLETED | Placebo and Celecoxib | 8 | |
| Overall Study | NOT COMPLETED | CP-195543 and Celecoxib | 15 |
Source ClinicalTrials.gov
Adverse events138
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eyelid oedema | Eye disorders | Placebo and Celecoxib | 0 | 35 | |
| other | Eyelid oedema | Eye disorders | CP-195543 and Celecoxib | 1 | 34 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo and Celecoxib | 0 | 35 | |
| other | Abdominal distension | Gastrointestinal disorders | CP-195543 and Celecoxib | 1 | 34 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo and Celecoxib | 1 | 35 | |
| other | Abdominal pain | Gastrointestinal disorders | CP-195543 and Celecoxib | 1 | 34 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Placebo and Celecoxib | 1 | 35 | |
| other | Abdominal pain lower | Gastrointestinal disorders | CP-195543 and Celecoxib | 0 | 34 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo and Celecoxib | 0 | 35 | |
| other | Abdominal pain upper | Gastrointestinal disorders | CP-195543 and Celecoxib | 1 | 34 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo and Celecoxib | ||
| Total, all-cause mortality | CP-195543 and Celecoxib | ||
| Total, other adverse events | Placebo and Celecoxib | 29 | 35 |
| Total, other adverse events | CP-195543 and Celecoxib | 31 | 34 |
| Total, serious adverse events | Placebo and Celecoxib | 1 | 35 |
| Total, serious adverse events | CP-195543 and Celecoxib | 2 | 34 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo and Celecoxib vs CP-195543 and Celecoxib: Number of Participants Who Withdrew From Study Due to Lack of Efficacy | Trial comparisons |
| Placebo and Celecoxib vs CP-195543 and Celecoxib: Number of Participants With Clinical Laboratory Abnormalities | Trial comparisons |
| Placebo and Celecoxib vs CP-195543 and Celecoxib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00424294
GET https://conductscience.org/api/trials/v1/NCT00424294/registered?page=2