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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00413699




Trial ID
NCT00413699
Ethics application status
Date submitted
18/12/2006
Date registered
18/12/2006
Date last updated
15/08/2018

Titles & IDs
Public title
Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis
Scientific title
A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis
Secondary ID [1] 0 0
2006-005035-19
Secondary ID [2] 0 0
A3921024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550

Experimental: Open-Label Active Treatment Enrolled from Phase 2 - Patients enrolling from Phase 2 studies

Experimental: Open-Label Active Treatment Enrolled from Phase 3 - Patients enrolling from Phase 3 studies


Treatment: Drugs: CP-690,550
5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

Treatment: Drugs: CP-690,550
10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports - 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
Timepoint [1] 0 0
Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug
Primary outcome [2] 0 0
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 - 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.
Timepoint [2] 0 0
Includes AEs for every visit and up to 999 days after last dose of study drug
Secondary outcome [1] 0 0
Percent of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses - 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.
Timepoint [1] 0 0
Every visit until study completion
Secondary outcome [2] 0 0
Area Under American College of Rheumatology (ACR) n Curve - No data were collected for this endpoint because it was removed from the protocol in a previous amendment.
Timepoint [2] 0 0
Not applicable as no data were collected for this endpoint.
Secondary outcome [3] 0 0
Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) - 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.
Timepoint [3] 0 0
Every visit until study completion
Secondary outcome [4] 0 0
Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and =3.2 - Percent participants with DAS28-4 (ESR) <2.6 and =3.2 and percent participants with DAS28-3 (CRP) <2.6 and =3.2. 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.
Timepoint [4] 0 0
Every visit until study completion
Secondary outcome [5] 0 0
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score - Change from baseline by visit. HAQ-DI scores range from 0 to 3, where lower score implies less disease. A reduction from baseline in score indicates an improvement in condition. A clinically meaningful decrease from baseline is defined as a decrease of at least 0.22 units.
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.
Timepoint [5] 0 0
Every visit until study completion
Secondary outcome [6] 0 0
Short-Form-36 Health Survey (SF-36) Score - Change from Baseline for Physical Component and Mental Component Scores by visit. SF-36 is a health status measure of 8 general health domains, each scored on a 0 to 100 scale: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These domains can be summarized as physical and mental component scores. The domain scores were "normed" and the resulting component scores treated as Z-scores with a scale of negative to positive infinity. A higher score implies less disease. The greater the change from baseline, the greater the improvement. 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.
Timepoint [6] 0 0
Every visit until study completion
Secondary outcome [7] 0 0
FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) - Change from Baseline Scores for each: FACIT Fatigue Scale (score range 0 to 52, higher score indicates higher quality of life and an increase from baseline score indicates improvement), EuroQol EQ 5D (index values derived from a measure of central tendency and a measure of dispersion, an increase from baseline indicates improvement, score range 0 to 1), Work Limitations (WL) Physical Demands (covers ability to perform job tasks that involve bodily strength, a decrease from baseline indicates improvement, score range 0 to 100, higher scores indicating greater limitation), and RA Healthcare Resource Utilization Work Performance in Past 3 Months on Days Bothered by RA (assesses healthcare use over previous 3 months, a decrease from baseline indicates improvement, score range 0 to 10).
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.
Timepoint [7] 0 0
Every visit until study completion
Secondary outcome [8] 0 0
Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study - Modified Total Sharp Score per visit. Baseline score was the last available assessment from the index study. The Modified Total Sharp Score measures disease progression; increased scores indicate disease progression. Score range 0 (normal) to 448 (worst possible total score). 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.
TSS=Total Sharp Score
Timepoint [8] 0 0
Every 6 months until study completion
Secondary outcome [9] 0 0
Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Pneumococcal Vaccine as Defined by = 2-fold Increase in Antibody Concentrations - Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by =2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in =6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.
95% CI is based on Clopper-Pearson exact method for response rate.
Timepoint [9] 0 0
From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary outcome [10] 0 0
Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Seasonal Influenza Vaccine as Defined by = 4-fold Increase in Antibody Titers - Number of participants achieving a satisfactory humoral response to the seasonal influenza vaccine as defined by =4-fold increase in antibody titers from visit 2 (vaccination baseline) in =2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.
95% CI is based on Clopper-Pearson exact method for response rate.
Timepoint [10] 0 0
From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary outcome [11] 0 0
Vaccine Sub-study. Percentage of Participants Achieving Protective Antibody Titers to the Seasonal Influenza Vaccine as Measured by a Hemagglutination Inhibition (HI) Assay Titer of = 1:40 in = 2 of 3 Influenza Antigens at Vaccine Sub-study Visit 3 and 4 - Number (%) of participants achieving protective antibody titers to the seasonal influenza vaccine as measured by an HAI assay titer of =1:40 in =2 of 3 influenza antigens measured at vaccine sub-study visits 3 and 4.
The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.
95% CI is based on Clopper-Pearson exact method for response rate.
Timepoint [11] 0 0
From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary outcome [12] 0 0
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by = 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 - Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by =2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in =6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.
95% CI is based on Clopper-Pearson exact method for response rate.
Timepoint [12] 0 0
From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary outcome [13] 0 0
Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 3 Influenza Antigens as Defined by = 4-fold Increase in Antibody Titers From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 - Number (%) of participants achieving a satisfactory humoral response to the seasonal influenza vaccine defined as =4-fold increase in antibody titers from visit 2 (vaccination baseline) in =2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2).
The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.
95% CI is based on Clopper-Pearson exact method for response rate.
Timepoint [13] 0 0
From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary outcome [14] 0 0
Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 - Geometric Mean Fold Increase From Baseline of Pneumococcal Antigens Measured at Visit 4.
n was the number of participants with valid and determinate assay results for the specified serotype at the given visit.
The stated number of participants analyzed was the total number of participants. The actual number of participants analyzed for some serotypes varied, and is provided where it differed from the total number of participants.
Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Timepoint [14] 0 0
From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary outcome [15] 0 0
Vaccine Sub-study. Fold Increase of Anti-influenza Antibody Levels to Each of the 3 Influenza Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 - Geometric Mean Fold Increase From Baseline of Influenza Antigens Measured at Visit 4.
n was the number of participants with valid and determinate assay results for the specified HAI strain at the given visit.
Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Timepoint [15] 0 0
From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary outcome [16] 0 0
Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4 - Mean pneumococcal concentrations (ug/mL) at vaccine baseline (visit 2) and post-vaccination visits (visits 3 and 4) by serotype. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed for each serotype varied, and is provided for each individually.
ug/mL=micrograms per milliliter
Timepoint [16] 0 0
From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary outcome [17] 0 0
Vaccine Sub-study. Titers of Anti-influenza Antibodies at Vaccine Sub-study Visit 3 and 4 - Mean influenza antibody titers at visits 3 and 4.
Timepoint [17] 0 0
From vaccine sub-study visit 2 (baseline) to sub-study visit 4

Eligibility
Key inclusion criteria
- Subjects who have participated in a randomized "qualifying" study of CP-690,550 for
the treatment of rheumatoid arthritis

Vaccine sub-study visit

- Subjects actively participating in Study A3921024 must have completed at least 3
months of continuous 10 mg BID CP-690,550 treatment in A3921024 as defined by >80%
compliance with prescribed dose consumption of CP-690,550 over the previous 3 months.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Serious medical conditions that would make treatment with CP-690,550 potentially
unsafe

Vaccine sub-study visit

1. Any documented influenza or pneumococcal infection within the last 3 months prior to
randomization in this study

2. Received any vaccine within 1 month prior to randomization in this study

3. Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years
of randomization in this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Optimus Clinical Research Pty. Ltd. - Kogarah
Recruitment hospital [2] 0 0
Rheumatology Research - Cairns
Recruitment hospital [3] 0 0
Rheumatology Research Unit Sunshine Coast - Maroochydore
Recruitment hospital [4] 0 0
Queen Elizabeth Hospital, Department of Rheumatology - Woodville
Recruitment hospital [5] 0 0
Emeritus Research - Malvern East
Recruitment hospital [6] 0 0
Goatcher Clinical Research Unit - Perth
Recruitment hospital [7] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3145 - Malvern East
Recruitment postcode(s) [6] 0 0
WA 6000 - Perth
Recruitment postcode(s) [7] 0 0
NSW2065 - St Leonards
Recruitment outside Australia
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Zlin
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the long-term effectiveness and safety of
CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study
only after participating in another "qualifying" study of CP-690,550

A sub-study will be conducted within the A3921024 study, this study will evaluate the immune
response to pneumococcal and influenza vaccines in patients receiving CP-690,550
Trial website
https://clinicaltrials.gov/show/NCT00413699
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries