Trial · NCT00413699
Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis
NCT00413699, Phase 3, Completed, Pfizer; results first posted 2018-03-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis. Trials, record NCT00413699. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00413699
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis
- NCT number
- NCT00413699
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,488 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Arthritis, Rheumatoid
- Interventions
- CP-690,550, CP-690,550
- First posted
- 2006-12-20
- Last updated
- 2018-10-30
- Other registries' IDs
- eudract:2006-005035-19
- Results first posted
- 2018-03-27
- Limitations and caveats
- 1 serious adverse event in the reporting group Tofacitinib 5 milligram (mg) twice daily (BID) of Initial Period could not be coded (septic shock and pneumonia) and has not been included.
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports | Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug | Treatment-emergent non serious AEs by System Organ Class (SOC) (all causalities) and Laboratory Test Abnormalities (without regard to baseline) The stated number of participants analyzed was the total number of participants in each group (AEs). The actual number of participants analyzed for each laboratory parameter varied, and is provided for each. Abs=absolute; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ESR=erythrocyte sedimentation rate; GGT=gamma glutamyl transferase; hgb=hemoglobin; HDL=high density lipids; LDL=low density lipids; LLN=lower limit of normal; qual=qualitative; Tot=total; ULN=upper limit of normal; WBC=white blood cell |
| Primary | Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) | Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months) | 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. |
| Primary | Extension Period: Number of Participants With Laboratory Test Abnormalities | Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months) | Criteria for laboratory abnormalities: hemoglobin (Hg), hematocrit, red blood cell (RBC), high density lipoprotein (HDL) cholesterol:\<0.8\*lower limit of normal (LLN), platelet\<0.5\*LLN/\>1.75\*upper limit of normal (ULN), white blood cell (WBC)\<0.6\*LLN/\>1.5\*ULN, lymphocyte, neutrophil, protein, albumin \<0.8\*LLN/\>1.2\*ULN, basophil, eosinophil, monocyte, low density lipoprotein (LDL) cholesterol: \>1.2\*ULN; bilirubin\>1.5\*ULN, aspartate amino transferase(AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:\>3.0\*ULN; blood urea nitrogen, creatinine, cholesterol, triglyceride:\>1.3\*ULN; sodium \<0.95\*LLN/\>1.05\*ULN, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN/\>1.1\*ULN; glucose\<0.6\*LLN/\>1.5\*ULN; Urine (specific gravity\<1.003/\>1.030, pH\<4.5/\>8, glucose, ketone, protein, blood/Hg(\>=1; RBC, WBC\>=20; creatinine kinase\>2\*ULN). |
| Primary | Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis | Includes AEs for every visit and up to 999 days after last dose of study drug | Treatment-emergent AEs by SOC (all causalities) - all participants, by time. Data presented for Post Month 96 includes data up to and including Month 114. |
| Primary | Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib | Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period | Long term safety and tolerability of Tofacitinib was measured as following: percentage (%) of participants with AEs, percentage of participants who discontinued due to AEs. An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. |
| Secondary | Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses | Every visit until study completion | The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented. ACR20 is defined as a 20% improvement from baseline in tender/painful joint count and swollen joint count, and at least 3 of the following 5 variables: Subject's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, Subject's Assessment of Arthritis Pain, Health Assessment Questionnaire - Disability Index, C-Reactive Protein (CRP). ACR50 is a 50% improvement and ACR70 a 70% improvement in these variables. |
| Secondary | Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses | Month 3, 6, 9 and 12 of Extension Period | ACR20=20 percent (%) improvement from baseline (Month 0 at entry of Initial Period) in tender/painful joint count and swollen joint count, and in at least 3 of 5 variables: participant's global assessment of arthritis (PtGA), physician's global assessment of arthritis (PGA), participant's assessment of arthritis pain (PtA), HAQ-DI, C-reactive protein. ACR50 is a 50% improvement and ACR70 is a 70% improvement in these variables. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PtA: participant assessed arthritis pain by 100 millimeter (mm) visual analogue scale, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. |
| Secondary | Initial Period: Area Under American College of Rheumatology (ACR) n Curve | Not applicable as no data were collected for this endpoint. | No data were collected for this endpoint because it was removed from the protocol in a previous amendment. |
| Secondary | Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) | Every visit until study completion | Descriptive statistics for DAS28-3 (CRP) and DAS28-4 (ESR). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented. DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula. The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of \>5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of \<2.6 indicates disease remission. |
| Secondary | Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 | Baseline (Month 0 at the entry of Initial period); Month 3, 6, 9 and 12 of Extension Period | DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR \[millimeter per hour\] or CRP \[milligram per liter\]). DAS28-4 also include score of general health (GH). GH is general health or participants' global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores = worse health condition). DAS28-3(CRP) = (0.56\*sqrt\[TJC28\] + 0.28\*sqrt\[SJC28\] + 0.36\*ln\[CRP+1\]) \*1.10 + 1.15) and DAS28-4(ESR) = (0.56\*sqrt\[TJC28\] + 0.28\*sqrt\[SJC28\] + 0.70\*ln\[ESR\] + 0.014\*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score ranges from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of \<=3.2 indicate low disease activity and score of \<2.6 indicate disease remission. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports | Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug | For abnormal laboratory results, those listed include both mandatory and optional laboratory tests. The number of participants analyzed is the number with at least one evaluable observation of the given laboratory test. Fasting lipids were only collected from participants who enrolled more than 14 days after last visit of their qualifying study. | Number of participants | NUMBER |
| PRIMARY | Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) | Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months) | Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Extension Period: Number of Participants With Laboratory Test Abnormalities | Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months) | Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis | Includes AEs for every visit and up to 999 days after last dose of study drug | The stated number of participants analyzed is the total number of participants enrolled in each group. The number of evaluable participants is the number remaining in the study in the given time period. | Number of participants | NUMBER |
| PRIMARY | Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib | Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period | Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants evaluable for specified categories. | Percentage of participants | NUMBER |
| SECONDARY | Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses | Every visit until study completion | The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point. | Percent of participants | NUMBER |
| SECONDARY | Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses | Month 3, 6, 9 and 12 of Extension Period | Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories. | Percentage of participants | NUMBER |
| SECONDARY | Initial Period: Area Under American College of Rheumatology (ACR) n Curve | Not applicable as no data were collected for this endpoint. | No data were collected for this endpoint as it was removed from the protocol in a protocol amendment. | ||
| SECONDARY | Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) | Every visit until study completion | The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point. | Score calculated from formula | MEAN |
| SECONDARY | Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 | Baseline (Month 0 at the entry of Initial period); Month 3, 6, 9 and 12 of Extension Period | Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories. | Scores on a scale | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group2,184
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | Participants with non-serious AEs | 991 | Number of participants | |
| Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports | Initial Period: Tofacitinib 10 mg BID | Participants with non-serious AEs | 2963 | Number of participants | |
| Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports | Initial Period: All Tofacitinib | Participants with non-serious AEs | 3954 | Number of participants | |
| Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | Blood and lymphatic system disorders | 159 | Number of participants | |
| Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports | Initial Period: Tofacitinib 10 mg BID | Blood and lymphatic system disorders | 395 | Number of participants | |
| Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports | Initial Period: All Tofacitinib | Blood and lymphatic system disorders | 554 | Number of participants | |
| Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | Cardiac disorders | 93 | Number of participants | |
| Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports | Initial Period: Tofacitinib 10 mg BID | Cardiac disorders | 185 | Number of participants | |
| Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports | Initial Period: All Tofacitinib | Cardiac disorders | 278 | Number of participants | |
| Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | Congenital, familial and genetic disorders | 6 | Number of participants |
1 to 10 of 2,184Source ClinicalTrials.gov
See all 2,184 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Period | STARTED | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | 1,123 | |
| Initial Period | STARTED | Initial Period: Tofacitinib 10 mg BID | 3,358 | |
| Initial Period | STARTED | Extension Period: Tofacitinib 5 mg | 0 | |
| Initial Period | COMPLETED | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | 484 | |
| Initial Period | COMPLETED | Initial Period: Tofacitinib 10 mg BID | 1,653 | |
| Initial Period | COMPLETED | Extension Period: Tofacitinib 5 mg | 0 | |
| Initial Period | NOT COMPLETED | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | 639 | |
| Initial Period | NOT COMPLETED | Initial Period: Tofacitinib 10 mg BID | 1,705 | |
| Initial Period | NOT COMPLETED | Extension Period: Tofacitinib 5 mg | 0 | |
| Extension Period | STARTED | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events3,192
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 | Anemia | Blood and lymphatic system disorders | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | 64 | 1,123 | |
| other | Anemia | Blood and lymphatic system disorders | Initial Period: Tofacitinib 10 mg BID | 176 | 3,358 | |
| other | Anemia | Blood and lymphatic system disorders | Initial Period: All Tofacitinib | 240 | 4,481 | |
| other | Anemia | Blood and lymphatic system disorders | Extension Period: Tofacitinib 5 mg | 0 | 48 | |
| other | Diarrhoea | Gastrointestinal disorders | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | 72 | 1,123 | |
| other | Diarrhoea | Gastrointestinal disorders | Initial Period: Tofacitinib 10 mg BID | 213 | 3,358 | |
| other | Diarrhoea | Gastrointestinal disorders | Initial Period: All Tofacitinib | 285 | 4,481 | |
| other | Diarrhoea | Gastrointestinal disorders | Extension Period: Tofacitinib 5 mg | 0 | 48 | |
| other | Nausea | Gastrointestinal disorders | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | 56 | 1,123 | |
| other | Nausea | Gastrointestinal disorders | Initial Period: Tofacitinib 10 mg BID | 175 | 3,358 |
1 to 10 of 3,192Source ClinicalTrials.gov
See all 3,192 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | 25 | 1,123 |
| Total, all-cause mortality | Initial Period: Tofacitinib 10 mg BID | 30 | 3,358 |
| Total, all-cause mortality | Initial Period: All Tofacitinib | 55 | 4,481 |
| Total, all-cause mortality | Extension Period: Tofacitinib 5 mg | 0 | 48 |
| Total, other adverse events | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | 807 | 1,123 |
| Total, other adverse events | Initial Period: Tofacitinib 10 mg BID | 2,422 | 3,358 |
| Total, other adverse events | Initial Period: All Tofacitinib | 3,229 | 4,481 |
| Total, other adverse events | Extension Period: Tofacitinib 5 mg | 3 | 48 |
| Total, serious adverse events | Initial Period: Tofacitinib 5 Milligram(mg) Twice Daily (BID) | 346 | 1,123 |
| Total, serious adverse events | Initial Period: Tofacitinib 10 mg BID | 997 | 3,358 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers24
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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GET https://conductscience.org/api/trials/v1/NCT00413699/registered?page=2