Trial · NCT01470612
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
NCT01470612, Phase 3, Completed, Pfizer; results first posted 2021-09-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis. Trials, record NCT01470612. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01470612
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
- NCT number
- NCT01470612
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 944 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Ulcerative Colitis
- Interventions
- CP-690,550, CP-690,550
- First posted
- 2011-11-11
- Last updated
- 2021-09-17
- Other registries' IDs
- eudract:2011-004581-14
- Results first posted
- 2021-09-17
Source ClinicalTrials.gov
Registered outcomes16
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 (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs. |
| Primary | Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs) | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | Serious infections were treated infections that required parenteral antimicrobial therapy or hospitalization for treatment or; met other criteria that required the infection to be classified as a serious adverse event (SAE). 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 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. |
| Primary | Number of Participants With Laboratory Test Abnormalities | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | Laboratory abnormalities: Hemoglobin, hematocrit, RBC: \<0.8\* LLN; reticulocytes (absolute \[Abs\], %): \<0.5\* LLN, \>1.5\* ULN; MCV, MCH: \<0.9\* LLN, \>1.1\* ULN; platelets:\<0.5\* LLN, \>1.75\* ULN; WBC:\<0.6\* LLN,\>1.5\* ULN; lymphocytes (Abs, %), total neutrophils (Abs,%):\<0.8\* LLN, \>1.2\* ULN; Basophils (Abs,%),eosinophils(Abs, %),monocytes(Abs, %):\>1.2\* ULN; total bilirubin,direct bilirubin,indirect bilirubin:\>1.5\* ULN; AST,ALT,gamma GT, LDH,ALP: \>3.0\* ULN; total protein,albumin: \<0.8\* LLN,\>1.2\* ULN: BUN,creatinine: \>1.3\* ULN;uric acid:\>1.2\* ULN; cholesterol,triglycerides: \>1.3\* ULN; cholesterol (HDL: \<0.8\* LLN; LDL: \>1.2\* ULN); sodium: \<0.95\* LLN, \>1.05\* ULN; potassium, chloride, calcium, bicarbonate: \<0.9\* LLN, \>1.1\* ULN; glucose: \<0.6\* LLN; creatine kinase \>2.0\* ULN; urine specific gravity: \<1.003; urine pH: \<4.5; urine (glucose,protein,blood,nitrite,leukocyte,esterase): \>=1; Urine (RBC,WBC): \>=20; urine epithelial cells:\>=6; urine (casts,granular casts,hyaline casts): \>1; urine bacteria:\>20. |
| Primary | Number of Participants With Vital Sign Abnormalities | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | Vital sign abnormalities included greater than or equal to (\>=) 30 millimeter of mercury \[mmHg\] increase in systolic blood pressure (BP), \>=30 mmHg decrease in systolic BP, Systolic BP (less than \[\<\] 90 mmHg), \>=20 mmHg increase in diastolic BP, \>=20 mmHg decrease in diastolic BP, diastolic BP (\<50 mmHg), pulse rate (\<40 beats per minute \[BPM\]), pulse rate (greater than \[\>\] 120 BPM). |
| Primary | Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | Physical examinations included weight, general appearance, head, ears, eyes, nose, mouth, throat, thyroid, skin (presence of rash), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), perianal, musculoskeletal, extremities, neurologic (mental status, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Clinically significant changes were judged by the investigator. |
| Primary | Number of Participants With Electrocardiogram (ECG) Abnormalities | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | ECG abnormalities criteria: maximum PR interval (\>=300 millisecond); maximum QRS complex (\>=200 millisecond); and maximum QT interval (\>=500 millisecond). |
| Primary | Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | Incidence rates for adjudicated cardiovascular (major adverse cardiovascular event \[MACE\]), malignancy (non-melanoma skin cancer \[NMSC\], malignancies excluding NMSC, opportunistic infections (OIs) (both herpes zoster and non herpes zoster OIs) and thromboembolic (venous thromboembolism) safety events were analyzed. This outcome measure was measured in participants with events per 100 participants-years (pt with events/100 pts-yrs). |
| Secondary | Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases | Months 2, 12, 24 and 36 | Remission in participants was defined as a total Mayo score of less than or equals to (\<=) 2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease. |
| Secondary | Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) | Months 2, 12, 24 and 36 | Remission in participants was defined as a total Mayo score of \<=2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease. |
| Secondary | Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases | Months 2, 12, 24 and 36 | Clinical remission in participants was defined as a total Mayo score of \<=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
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 (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | Safety analysis set (SAS) included all participants who received at least 1 dose of study medication in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs) | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | SAS included all participants who received at least 1 dose of study medication in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Test Abnormalities | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | SAS included all participants who received at least 1 dose of study medication in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Vital Sign Abnormalities | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | SAS included all participants who received at least 1 dose of study medication in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number analyzed signifies participants evaluable at each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | SAS included all participants who received at least 1 dose of study medication in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Electrocardiogram (ECG) Abnormalities | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | SAS included all participants who received at least 1 dose of study medication in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number analyzed signifies participants evaluable at each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events | Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group) | SAS included all participants who received at least 1 dose of study medication in this study. | pt with events/100 pts-yrs | NUMBER |
| SECONDARY | Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases | Months 2, 12, 24 and 36 | FAS included all participants who received at least 1 dose of study medication in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number analyzed signifies participants evaluable at each specified time point. Data is presented for observed cases, no imputation technique was applied. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) | Months 2, 12, 24 and 36 | FAS included all participants who received at least 1 dose of study medication in this study. NRI method was used for missing data except for visits after a participant advanced to other studies where LOCF method was used. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases | Months 2, 12, 24 and 36 | FAS included all participants who received at least 1 dose of study medication in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number analyzed signifies participants evaluable at each specified time point. Data is presented for observed cases, no imputation technique was applied. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group216
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 (TEAEs) and Serious Adverse Events (SAEs) | Tofacitinib 5 mg BID | Participants with AEs | 154 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Tofacitinib 10 mg BID | Participants with AEs | 626 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Tofacitinib 5 mg BID | Participants with SAEs | 39 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Tofacitinib 10 mg BID | Participants with SAEs | 147 | Participants | |
| Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs) | Tofacitinib 5 mg BID | 8 | Participants | ||
| Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs) | Tofacitinib 10 mg BID | 31 | Participants | ||
| Number of Participants With Laboratory Test Abnormalities | Tofacitinib 5 mg BID | 162 | Participants | ||
| Number of Participants With Laboratory Test Abnormalities | Tofacitinib 10 mg BID | 670 | Participants | ||
| Number of Participants With Vital Sign Abnormalities | Tofacitinib 5 mg BID | Systolic BP (>=30 mmHg increase) | 20 | Participants | |
| Number of Participants With Vital Sign Abnormalities | Tofacitinib 10 mg BID | Systolic BP (>=30 mmHg increase) | 113 | Participants |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 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 5 mg BID | 175 | |
| Overall Study | STARTED | Tofacitinib 10 mg BID | 769 | |
| Overall Study | COMPLETED | Tofacitinib 5 mg BID | 91 | |
| Overall Study | COMPLETED | Tofacitinib 10 mg BID | 104 | |
| Overall Study | NOT COMPLETED | Tofacitinib 5 mg BID | 84 | |
| Overall Study | NOT COMPLETED | Tofacitinib 10 mg BID | 665 |
Source ClinicalTrials.gov
Adverse events454
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 | Anaemia | Blood and lymphatic system disorders | Tofacitinib 5 mg BID | 3 | 175 | |
| other | Anaemia | Blood and lymphatic system disorders | Tofacitinib 10 mg BID | 36 | 769 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Tofacitinib 5 mg BID | 6 | 175 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Tofacitinib 10 mg BID | 13 | 769 | |
| other | Abdominal pain | Gastrointestinal disorders | Tofacitinib 5 mg BID | 6 | 175 | |
| other | Abdominal pain | Gastrointestinal disorders | Tofacitinib 10 mg BID | 47 | 769 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Tofacitinib 5 mg BID | 4 | 175 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Tofacitinib 10 mg BID | 24 | 769 | |
| other | Colitis ulcerative | Gastrointestinal disorders | Tofacitinib 5 mg BID | 44 | 175 | |
| other | Colitis ulcerative | Gastrointestinal disorders | Tofacitinib 10 mg BID | 131 | 769 |
1 to 10 of 454Source ClinicalTrials.gov
See all 454 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tofacitinib 5 mg BID | 0 | 175 |
| Total, all-cause mortality | Tofacitinib 10 mg BID | 6 | 769 |
| Total, other adverse events | Tofacitinib 5 mg BID | 134 | 175 |
| Total, other adverse events | Tofacitinib 10 mg BID | 550 | 769 |
| Total, serious adverse events | Tofacitinib 5 mg BID | 39 | 175 |
| Total, serious adverse events | Tofacitinib 10 mg BID | 147 | 769 |
Source ClinicalTrials.gov
Papers27
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tofacitinib 5 mg BID vs Tofacitinib 10 mg BID: Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs) | Trial comparisons |
| Tofacitinib 5 mg BID vs Tofacitinib 10 mg BID: Number of Participants With Laboratory Test Abnormalities | Trial comparisons |
| Tofacitinib 5 mg BID vs Tofacitinib 10 mg BID: deaths from any cause | Trial comparisons |
| Tofacitinib 5 mg BID vs Tofacitinib 10 mg BID: Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline | Trial comparisons |
| Tofacitinib 5 mg BID vs Tofacitinib 10 mg BID: 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/NCT01470612
GET https://conductscience.org/api/trials/v1/NCT01470612/results?page=2