Trial · NCT01163253
A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis
NCT01163253, Phase 3, Terminated, Pfizer; results first posted 2017-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis. Trials, record NCT01163253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01163253
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis
- NCT number
- NCT01163253
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,867 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Psoriasis
- Interventions
- CP-690,550, CP-690,550
- First posted
- 2010-07-15
- Last updated
- 2017-06-26
- Other registries' IDs
- eudract:2010-020002-15
- Results first posted
- 2017-06-26
Source ClinicalTrials.gov
Registered outcomes78
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 were events between first dose of study drug and up to 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. |
| Primary | Number of Adverse Events (AEs) by Severity | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant's usual function; b) moderate: AEs interfered to some extent with participant's usual function; c) severe: AEs interfered significantly with participant's usual function. |
| Primary | Number of Participants With Laboratory Abnormalities | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell \<0.8\*lower limit of normal \[LLN\]; reticulocyte\<0.5\*LLN,\>1.5\*ULN; platelets\<0.5\*LLN,\>1.75\* upper limit of normal \[ULN\]; WBC\<0.6\*LLN, \>1.5\*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes\<0.8\*LLN; \>1.2\*ULN; coagulation (prothrombin \[PT\], PT ratio\>1.1\*ULN) liver function (bilirubin\>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT\>0.3\*ULN, protein, albumin\<0.8\*LLN; \>1.2\*ULN, globulin\<0.5\*LLN; \>1.5\*ULN); renal function (blood urea nitrogen, creatinine\>1.3\*ULN); electrolytes(sodium\<0.95\* LLN; \>1.05\* ULN, potassium, chloride, calcium, bicarbonate\<0.9\*LLN; \>1.1\*ULN), chemistry (glucose\<0.6\*LLN; \>1.5\* ULN), urinalysis (pH \<4.5;\>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase\>=1; RBC, WBC\>=20); lipids (cholesterol \[C\], LDL-C \>1.3\*ULN, HDL-C\<0.8\*LLN, triglycerides\>1.3\* ULN), hormones(T4, T3, T4, TSH\<0.8\* LLN; \>1.2\* ULN). |
| Primary | Change From Baseline in Hemoglobin Level at Month 1 | Baseline, Month 1 | |
| Primary | Change From Baseline in Hemoglobin Level at Month 3 | Baseline, Month 3 | |
| Primary | Change From Baseline in Hemoglobin Level at Month 6 | Baseline, Month 6 | |
| Primary | Change From Baseline in Hemoglobin Level at Month 12 | Baseline, Month 12 | |
| Primary | Change From Baseline in Hemoglobin Level at Month 24 | Baseline, Month 24 | |
| Primary | Change From Baseline in Hemoglobin Level at Month 36 | Baseline, Month 36 | |
| Primary | Change From Baseline in Hemoglobin Level at Month 48 | Baseline, Month 48 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 registered outcomesOutcomes78
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | Safety analysis set included all participants who received at least 1 dose of study drug. | participants | NUMBER |
| PRIMARY | Number of Adverse Events (AEs) by Severity | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | Safety analysis set included all participants who received at least 1 dose of study drug. | adverse events | NUMBER |
| PRIMARY | Number of Participants With Laboratory Abnormalities | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | participants | NUMBER |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 1 | Baseline, Month 1 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies participants evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | gram per deciliter (g/dL) | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 3 | Baseline, Month 3 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | g/dL | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 6 | Baseline, Month 6 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | g/dL | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 12 | Baseline, Month 12 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | g/dL | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 24 | Baseline, Month 24 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | g/dL | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 36 | Baseline, Month 36 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | g/dL | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 48 | Baseline, Month 48 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | g/dL | MEAN |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 outcomesResults by group906
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Tofacitinib 10 mg | AEs | 1876 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Tofacitinib 5 mg or 10 mg | AEs | 490 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Tofacitinib 10 mg | SAEs | 304 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Tofacitinib 5 mg or 10 mg | SAEs | 88 | participants | |
| Number of Adverse Events (AEs) by Severity | Tofacitinib 10 mg | Mild | 5354 | adverse events | |
| Number of Adverse Events (AEs) by Severity | Tofacitinib 5 mg or 10 mg | Mild | 1749 | adverse events | |
| Number of Adverse Events (AEs) by Severity | Tofacitinib 10 mg | Moderate | 3268 | adverse events | |
| Number of Adverse Events (AEs) by Severity | Tofacitinib 5 mg or 10 mg | Moderate | 766 | adverse events | |
| Number of Adverse Events (AEs) by Severity | Tofacitinib 10 mg | Severe | 410 | adverse events | |
| Number of Adverse Events (AEs) by Severity | Tofacitinib 5 mg or 10 mg | Severe | 136 | adverse events |
1 to 10 of 906Source ClinicalTrials.gov
See all 906 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tofacitinib 10 mg | 2,281 | |
| Overall Study | STARTED | Tofacitinib 5 mg or 10 mg | 586 | |
| Overall Study | COMPLETED | Tofacitinib 10 mg | 0 | |
| Overall Study | COMPLETED | Tofacitinib 5 mg or 10 mg | 0 | |
| Overall Study | NOT COMPLETED | Tofacitinib 10 mg | 2,281 | |
| Overall Study | NOT COMPLETED | Tofacitinib 5 mg or 10 mg | 586 |
Source ClinicalTrials.gov
Adverse events634
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 | Diarrhoea | Gastrointestinal disorders | Tofacitinib 10 mg | 73 | 2,281 | |
| other | Diarrhoea | Gastrointestinal disorders | Tofacitinib 5 mg or 10 mg | 32 | 586 | |
| other | Bronchitis | Infections and infestations | Tofacitinib 10 mg | 134 | 2,281 | |
| other | Bronchitis | Infections and infestations | Tofacitinib 5 mg or 10 mg | 48 | 586 | |
| other | Herpes zoster | Infections and infestations | Tofacitinib 10 mg | 136 | 2,281 | |
| other | Herpes zoster | Infections and infestations | Tofacitinib 5 mg or 10 mg | 33 | 586 | |
| other | Influenza | Infections and infestations | Tofacitinib 10 mg | 126 | 2,281 | |
| other | Influenza | Infections and infestations | Tofacitinib 5 mg or 10 mg | 23 | 586 | |
| other | Nasopharyngitis | Infections and infestations | Tofacitinib 10 mg | 476 | 2,281 | |
| other | Nasopharyngitis | Infections and infestations | Tofacitinib 5 mg or 10 mg | 122 | 586 |
1 to 10 of 634Source ClinicalTrials.gov
See all 634 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tofacitinib 10 mg | ||
| Total, all-cause mortality | Tofacitinib 5 mg or 10 mg | ||
| Total, other adverse events | Tofacitinib 10 mg | 1,415 | 2,281 |
| Total, other adverse events | Tofacitinib 5 mg or 10 mg | 394 | 586 |
| Total, serious adverse events | Tofacitinib 10 mg | 304 | 2,281 |
| Total, serious adverse events | Tofacitinib 5 mg or 10 mg | 88 | 586 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tofacitinib 10 mg vs Tofacitinib 5 mg or 10 mg: Number of Participants With Malignancy Events | Trial comparisons |
| Tofacitinib 10 mg vs Tofacitinib 5 mg or 10 mg: Number of Participants With Electrocardiogram (ECG) Abnormalities | Trial comparisons |
| Tofacitinib 10 mg vs Tofacitinib 5 mg or 10 mg: Number of Participants With Adjudicated Cardiovascular Events | Trial comparisons |
| Tofacitinib 10 mg vs Tofacitinib 5 mg or 10 mg: Number of Participants With Laboratory Abnormalities | Trial comparisons |
| Tofacitinib 10 mg vs Tofacitinib 5 mg or 10 mg: Number of Participants With Clinically Significant Change From Baseline in Physical Examination | Trial comparisons |
| Tofacitinib 10 mg vs Tofacitinib 5 mg or 10 mg: 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/NCT01163253
GET https://conductscience.org/api/trials/v1/NCT01163253/registered?page=2