Trial · NCT02969044
Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
NCT02969044, Phase 2, Completed, Pfizer; results first posted 2018-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate. Trials, record NCT02969044. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02969044
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
- NCT number
- NCT02969044
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Rheumatoid Arthritis
- Interventions
- Placebo, PF-06651600
- First posted
- 2016-11-21
- Last updated
- 2018-12-04
- Other registries' IDs
- eudract:2016-002862-30
- Results first posted
- 2018-12-04
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 | Baseline, Week 8 | The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analogue scale (VAS) scale ranging from 0 to 10 centimeter (cm), where higher scores=greater affection due to disease activity, and C-reactive protein (CRP) measured in terms of milligram per deciliter (mg/dL). SDAI total score= 0 to 86. SDAI greater than or equal to (\<=) 3.3 indicates disease remission, greater than (\>) 3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity. |
| Secondary | Number of Participants With Vital Signs Abnormalities | Baseline up to Week 12 | Criteria: sitting pulse rate less than (\<) 40 beats per minute (bpm) or \>120 bpm; sitting systolic blood pressure (SBP) \>=30 millimeters of mercury (mmHg) change from baseline in same posture or \<90 mmHg; diastolic blood pressure (DBP) \>=20 mmHg change from baseline in same posture or \<50 mmHg. Only those categories in which at least one participant had abnormality, were reported in this outcome measure. |
| Secondary | Number of Participants With Laboratory Abnormalities | Baseline up to Week 12 | Hemoglobin(Hb);hematocrit;RBC count:\<0.8\*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:\<0.9\*LLN or\>1.1\*upper limit of normal (ULN), platelet:\<0.5\*LLN or \>1.75\*ULN,reticulocytes \<0.5\*LLN or \>1.5\*ULN,leukocytes \<0.6\*LLN or \>1.5\*ULN,lymphocyte;neutrophil: \<0.8\*LLN or \>1.2\*ULN,basophil;eosinophil; monocyte:\>1.2\*ULN,partial thromboplastin time,prothrombin time\>1.1\*ULN,bilirubin\>1.5\*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:\>3.0\*ULN,protein;albumin;LDL, HDL cholesterol:\<0.8\*LLN or \>1.2\*ULN;urea nitrogen;creatinine: \>1.3\*ULN, urate \>1.2\*ULN, sodium\<0.95\*LLN or \>1.05\*ULN, potassium; chloride;calcium; bicarbonate:\<0.9\*LLN or \>1.1\*ULN,glucose \<0.6\*LLN or \>1.5\*ULN, creatine kinase: \>2.0\*ULN;urine pH \<4.5 or \>8,urine glucose or ketones\>=1,urine protein;urineHb\>=1,urobilinogen;bilirubin;nitrite;leukocyte esterase \>=1,urine erythrocytes, leukocytes\>=20,hyaline cast\>1,bacteria\>20. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 12 | 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 are events between first dose of study drug and up to Week 12 that were absent before treatment or that worsened relative to pretreatment state. |
| Secondary | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 | Baseline, Week 1, 2, 4 and 6 | The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity. |
| Secondary | Remission Rate Based on Simple Disease Activity Index Score | Week 4, 6 and 8 | Remission rate was defined as percentage of participants with disease remission. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity. |
| Secondary | Remission Rate Based on Disease Activity Score (DAS28-3 [ESR]) | Week 4, 6 and 8 | Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) \<2.6 = remission. |
| Secondary | Remission Rate Based on Disease Activity Score (DAS28-4[ESR]) | Week 4, 6 and 8 | Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. |
| Secondary | Remission Rate Based on Disease Activity Score (DAS28-3 [CRP]) | Week 4, 6 and 8 | Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). 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. |
| Secondary | Remission Rate Based on Disease Activity Score (DAS28-4 [CRP]) | Week 4, 6 and 8 | Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP): calculated from SJC, TJC, CRP (mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) \<2.6=remission, \<3.2=low disease activity, \>=3.2-5.1=moderate disease activity and \>5.1=high disease activity. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 | Baseline, Week 8 | ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Vital Signs Abnormalities | Baseline up to Week 12 | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Abnormalities | Baseline up to Week 12 | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 12 | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 | Baseline, Week 1, 2, 4 and 6 | ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only. | units on a scale | MEAN |
| SECONDARY | Remission Rate Based on Simple Disease Activity Index Score | Week 4, 6 and 8 | ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). | percentage of participants | NUMBER |
| SECONDARY | Remission Rate Based on Disease Activity Score (DAS28-3 [ESR]) | Week 4, 6 and 8 | ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). | percentage of participants | NUMBER |
| SECONDARY | Remission Rate Based on Disease Activity Score (DAS28-4[ESR]) | Week 4, 6 and 8 | ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). | percentage of participants | NUMBER |
| SECONDARY | Remission Rate Based on Disease Activity Score (DAS28-3 [CRP]) | Week 4, 6 and 8 | ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). | percentage of participants | NUMBER |
| SECONDARY | Remission Rate Based on Disease Activity Score (DAS28-4 [CRP]) | Week 4, 6 and 8 | ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). | percentage of participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group184
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 | PF-06651600 | Baseline | 45.15 | Standard Deviation 13.164 | units on a scale |
| Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 | Placebo | Baseline | 44.85 | Standard Deviation 13.976 | units on a scale |
| Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 | PF-06651600 | Change at Week 8 | -26.11 | Standard Deviation 14.834 | units on a scale |
| Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 | Placebo | Change at Week 8 | -17.38 | Standard Deviation 18.176 | units on a scale |
| Number of Participants With Vital Signs Abnormalities | PF-06651600 | Sitting DBP >=20 mmHg increase from baseline | 3 | Participants | |
| Number of Participants With Vital Signs Abnormalities | Placebo | Sitting DBP >=20 mmHg increase from baseline | 0 | Participants | |
| Number of Participants With Vital Signs Abnormalities | PF-06651600 | Sitting DBP >=20 mmHg decrease from baseline | 0 | Participants | |
| Number of Participants With Vital Signs Abnormalities | Placebo | Sitting DBP >=20 mmHg decrease from baseline | 1 | Participants | |
| Number of Participants With Laboratory Abnormalities | PF-06651600 | 42 | Participants | ||
| Number of Participants With Laboratory Abnormalities | Placebo | 28 | Participants |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-06651600 | 42 | |
| Overall Study | STARTED | Placebo | 28 | |
| Overall Study | COMPLETED | PF-06651600 | 37 | |
| Overall Study | COMPLETED | Placebo | 22 | |
| Overall Study | NOT COMPLETED | PF-06651600 | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events56
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 | Lymphopenia | Blood and lymphatic system disorders | PF-06651600 | 3 | 42 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo | 0 | 28 | |
| other | Abdominal distension | Gastrointestinal disorders | PF-06651600 | 1 | 42 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 0 | 28 | |
| other | Glossitis | Gastrointestinal disorders | PF-06651600 | 1 | 42 | |
| other | Glossitis | Gastrointestinal disorders | Placebo | 0 | 28 | |
| other | Nausea | Gastrointestinal disorders | PF-06651600 | 1 | 42 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 28 | |
| other | Vomiting | Gastrointestinal disorders | PF-06651600 | 1 | 42 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 0 | 28 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-06651600 | 0 | 42 |
| Total, all-cause mortality | Placebo | 0 | 28 |
| Total, other adverse events | PF-06651600 | 20 | 42 |
| Total, other adverse events | Placebo | 5 | 28 |
| Total, serious adverse events | PF-06651600 | 0 | 42 |
| Total, serious adverse events | Placebo | 0 | 28 |
Source ClinicalTrials.gov
Papers3
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PF-06651600 vs Placebo: Number of Participants With Laboratory Abnormalities | Trial comparisons |
| PF-06651600 vs Placebo: deaths from any cause | Trial comparisons |
| PF-06651600 vs Placebo: 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/NCT02969044
GET https://conductscience.org/api/trials/v1/NCT02969044/results?page=2