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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005689-39 | EudraCT Number |
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This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofacitinib 2 mg | Experimental |
| |
| Tofacitinib 5 mg | Experimental |
| |
| Tofacitinib 10 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib 2 mg | Drug | 4 blinded tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12 | The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing. | Week 12 |
| Percentage of Participants Achieving ASAS20 at Week 12 | The supportive analysis of this outcome measure was performed using the normal approximation for two proportions. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8 | Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Medical Imaging | Indian Wells | California | 92210 | United States | ||
| Desert Medical Advances |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39695887 | Derived | Deodhar A, Akar S, Curtis JR, El-Zorkany B, Magrey M, Wang C, Wu J, Makgoeng SB, Vranic I, Menon S, Fleishaker DL, Diehl AM, Fallon L, Yndestad A, Landewe RBM. Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis. Adv Rheumatol. 2024 Dec 18;64(1):87. doi: 10.1186/s42358-024-00402-x. | |
| 39636343 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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In total 208 participants were randomized to double-blind treatment; 52 to each treatment group (tofacitinib 2 milligrams [mg] twice daily [BID], tofacitinib 5 mg BID, tofacitinib 10 mg BID, and placebo BID). One participant was randomized to the placebo group but did not receive study drug, as such only 207 participants received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib 2 mg BID | Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the morning [AM] and afternoon [PM]) for a total of 12 weeks. |
| FG001 | Tofacitinib 5 mg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tofacitinib 5 mg | Drug | 4 blinded tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks |
|
| Tofacitinib 10 mg | Drug | 4 blinded tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks |
|
| Placebo | Drug | 4 blinded tablets (two 1 mg and two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks |
|
| Baseline, Week 2, Week 4, Week 8 |
| Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score of the Sacroiliac (SI) Joints at Week 12 | SPARCC scoring consists of assessing six SI joint MRI image coronal slices representing the largest proportion of the synovial compartment of the SI joints for edema. The maximum score per slice was 2 and 12 for all 6 slices. The total minimum and maximum score for all SI joints across 6 slices is 0 to 72 and higher scores indicate more inflammation. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available. | Baseline, Week 12 |
| Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12 | SPARCC scoring of the magnetic resonance imaging (MRI) of the spine consists of assessing six disco-vertebral units (DVU) with 3 consecutive sagittal slices at each DVU. The minimum and maximum SPARCC score for all 6 DVUs is 0 to 108, with higher scores indicating more damage. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available. | Baseline, Week 12 |
| Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12 | Berlin modification of the ASspiMRI is a measure of acute lesion as determined by short-tau inversion recovery (STIR) sequences. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, were scored in a single dimension, which is represented the highest level of inflammation in that particular DVU. Total spine ASspiMRI scores can range from 0-69 with higher scores indicating more disease activity. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available. | Baseline, Week 12 |
| Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12 | ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12 | ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12 | The ASDAS(CRP) is a derived score that uses back pain, duration of morning stiffness, Patient's Global Assessment of their disease and peripheral pain/swelling. The formula used for calculating the ASDAS (CRP)is: 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12 | The ASDAS clinically important improvement was calculated from the ASDAS data. The ASDAS clinically important improvement is defined as change (decrease) from baseline of ≥1.1 units. Missing data were handled by NRI/LOCF. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12 | The ASDAS major improvement was calculated from the ASDAS data. The ASDAS major improvement was defined as change (decrease) from baseline of ≥2.0 units. Missing data were handled by NRI/LOCF. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12 | The ASDAS inactive disease was calculated from the ASDAS data. The ASDAS inactive disease was defined as ASDAS <1.3 units. Missing data were handled by NRI/LOCF. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12 | BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The final BASDAI score averages the individual assessments for a final score range of 0-10. Negative values indicate improvement. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12 | BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. The final BASDAI score range from 0-10. A positive response was defined as a 50% improvement in the BASDAI from baseline. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12 | BASFI is a validated self-assessment tool that determines the degree of physical functional limitation in Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0=easy, 10=impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions with lower scores indicating better physical function. The higher the negative value the better the improvement. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12 | BASMI is an objective measure of spinal mobility and was completed by a blinded assessor. The BASMI score is composed of 5 clinical measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. The derived score used the average of the 5 assessments on a scale of 0-10 scale with higher scores indicating more impairment of spinal mobility. BASMI was analyzed using the linear function method. The higher the negative value the better the improvement. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12 | Assessment of enthesitis of 13 sites was performed in the following, 1st costochondral joint left and right, 7th costochondral joint left and right, posterior superior iliac spine left and right, anterior superior iliac spine left and right, iliac crest left and right, 5th lumbar spinous process and proximal insertion of Achilles tendon left and right. Each site was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness). | Baseline, Week 4, Week 8, Week 12 |
| Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History | Participants were assessed at Baseline, Week 12 and Week 16 (Follow-up) to determine if they had specific Ankylosing Spondylitis medical history or changes in specific Ankylosing Spondylitis medical history which included: Inflammatory Bowel Disease (IBD), Peripheral Articular Involvement (PAI; as assessed by swollen joint count), psoriasis (PSO) and uveitis (UVE). | Baseline, Week 12 and Follow-up |
| Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12 | This assessment was performed by the blinded assessor using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints) for determination of the total number of swollen joints. Forty-four joints were assessed for swelling on left and right side and included the following: sternoclaviculars, acromioclaviculars, shoulders, elbows, wrists, metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (II, III, IV, V), knees, ankles, and metatarsophalangeals (I, II, III, IV, V). Artificial joints were not assessed. A negative change means improvement. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12 | Chest expansion, measured in centimeters (cm), is defined as the difference in the thoracic circumference during full expiration versus full inspiration. This was measured at the 4th intercostal space. The difference between maximal inspiration and expiration of the two attempts was recorded. The better of the two attempts was used to calculate chest expansion. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12 | SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=no functioning, 100=highest level of functioning). Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available. | Baseline, Week 12 |
| Change From Baseline in EuroQol EQ-5D Health State Profile (EQ-5D) Utility Score at Week 12 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]). | Baseline, Week 12 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12 | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Palm Desert |
| California |
| 92260 |
| United States |
| Arthritis & Rheumatology Associates | Clearwater | Florida | 33756 | United States |
| Millennium Research | Ormond Beach | Florida | 32174 | United States |
| Southwest Florida Clinical Research Center | Tampa | Florida | 33609 | United States |
| Covance Central Laboratory Services,Inc | Indianapolis | Indiana | 46214 | United States |
| Klein & Associates, M.D., P.A. | Hagerstown | Maryland | 21740 | United States |
| Progressive Radiology | Hagerstown | Maryland | 21740 | United States |
| Advanced Medical Imaging (MRI center) | Lincoln | Nebraska | 68506 | United States |
| Arthritis Center of Nebraska (X-ray center) | Lincoln | Nebraska | 68516 | United States |
| Physician Research Collaboration, LLC | Lincoln | Nebraska | 68516 | United States |
| Charlotte Radiology/ Carolina Imaging Services | Ballantyne | North Carolina | 28277 | United States |
| Joint and Muscle Research Institute | Charlotte | North Carolina | 28204 | United States |
| Presbyterian Imaging | Charlotte | North Carolina | 28207 | United States |
| Paramount Medical Research & Consulting, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Premier Physicians Centers | Westlake | Ohio | 44145 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Clinical Research Center of Reading, LLC | Wyomissing | Pennsylvania | 19610 | United States |
| Investigational Drug Service | Seatle | Washington | 98122 | United States |
| Seattle Rheumatology Associates | Seattle | Washington | 98122 | United States |
| Arthritis Northwest, PLLC | Spokane | Washington | 99204 | United States |
| Institut de Rhumatologie de Montreal | Montreal | Quebec | H2L 1S6 | Canada |
| G.R.M.O. Inc | Québec | Quebec | G1V 3M7 | Canada |
| Artroscan s.r.o. | Ostrava | Czech Republic | 722 00 | Czechia |
| Revmatologicky ustav | Prague | 128 50 | Czechia |
| Revmatologicka ambulance | Prague | 140 00 | Czechia |
| Mediscan Group s.r.o. | Praha 11- Chodov | 14800 | Czechia |
| Medical Plus | Uherské Hradiště | 68601 | Czechia |
| Charité Universitaetsmedizin Berlin | Berlin | 12203 | Germany |
| Praxis fuer klinische Studien | Hamburg | 22415 | Germany |
| Gemeinschaftspraxis Dres. von Hinueber / Demary | Hildesheim | 31134 | Germany |
| Immunologisches Zentrum Vogelsang-Gommern GmbH | Vogelsang-Gommern | 39245 | Germany |
| Dr. Rethy Pál Korhaz es Rendelointezet, Reumatologia | Békéscsaba | 5600 | Hungary |
| Orszagos Reumatologiai es Fiziotherapias Intezet II. Reumatologiai Osztaly | Budapest | 1023 | Hungary |
| Qualiclinic Kft | Budapest | 1036 | Hungary |
| Synexus Magyarorszag Kft. - Synexus Hungary Clinical Research Centre | Budapest | 1036 | Hungary |
| Debreceni Egyetem Orvos- és Egészségtudományi Centrum | Debrecen | 4032 | Hungary |
| CRU Hungary Kft. | Szikszó | 3800 | Hungary |
| Csolnoky Ferenc Korhaz Reumatologiai Osztaly | Veszprém | H-8200 | Hungary |
| NZOZ Lecznica MAK-MED s.c. | Nadarzyn | Masovian Voivodeship | 05-830 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorob Kostno-Stawowych | Bialystok | 15- 879 | Poland |
| Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy | Bydgoszcz | 85-168 | Poland |
| Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska | Elblag | 82-300 | Poland |
| Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Katowice | Katowice | 40-954 | Poland |
| Malopolskie Centrum Medyczne S.C. | Krakow | 30-510 | Poland |
| Zespol Poradni Specjalistycznych Reumed Filia Onyksowa | Lublin | 20-582 | Poland |
| Twoja Przychodnia - Centrum Medyczne Nowa Sol | Nowa Sól | 67-100 | Poland |
| NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu | Torun | 87-100 | Poland |
| Federal State Budgetary Institution | Moscow | 115522 | Russia |
| OOO AVA-PETER "Scandinavia clinic" | Saint Petersburg | 191014 | Russia |
| Saint-Petersburg State Budgetary Healthcare Institution | Sestroretsk | 197706 | Russia |
| SBEI HPE Ural State Medical University of MoH of RF based on Municipal Budgetary Institution | Yekaterinburg | 620149 | Russia |
| Chonnam National University Hospital | Gwangju | 501-757 | South Korea |
| INHA University Hospital | Incheon | 400-711 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Ajou University Hospital | Suwon | 443-721 | South Korea |
| Complexo Hospitalario Universitario A Coruna | A Coruña | A Coruna | 15006 | Spain |
| Hospital Clinico Universitario Santiago de Compostela | Santiago de Compostela | A Coruna | 15706 | Spain |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | Cordoba | 14004 | Spain |
| Hospital Universitario De La Paz | Madrid | 28046 | Spain |
| Corporacio Sanitaria Parc Tauli | Sabadell | 08208 | Spain |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 80756 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 40201 | Taiwan |
| China medical university hospital | Taichung | 40447 | Taiwan |
| Norton H, Sliwinska-Stanczyk P, Hala T, El-Zorkany B, Stockert L, Mundayat R, Wang L, Ritchlin CT. Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials. Rheumatol Ther. 2025 Feb;12(1):67-84. doi: 10.1007/s40744-024-00726-6. Epub 2024 Dec 5. |
| 38825359 | Derived | Deodhar A, Baraliakos X, Magrey M, Gensler LS, Thorat AV, Pemmaraju SK, Cadatal MJ, Nash P. Efficacy and Safety of Tofacitinib in Ankylosing Spondylitis by Baseline C-Reactive Protein Level: Post Hoc Analysis of Phase II and Phase III Clinical Trials. J Rheumatol. 2024 Aug 1;51(8):772-780. doi: 10.3899/jrheum.2023-1198. |
| 38696034 | Derived | Kristensen LE, Deodhar A, Leung YY, Vranic I, Mortezavi M, Fallon L, Yndestad A, Kinch CD, Gladman DD. Risk Stratification of Patients with Psoriatic Arthritis and Ankylosing Spondylitis for Treatment with Tofacitinib: A Review of Current Clinical Data. Rheumatol Ther. 2024 Jun;11(3):487-499. doi: 10.1007/s40744-024-00662-5. Epub 2024 May 2. |
| 37909386 | Derived | Magrey M, Wei JC, Yndestad A, Bushmakin AG, Cappelleri JC, Dina O, Deodhar A. Relationships of Work Productivity and Activity Impairment With Patient-Reported Outcomes in Ankylosing Spondylitis: Results From Two Trials. Arthritis Care Res (Hoboken). 2024 Mar;76(3):359-365. doi: 10.1002/acr.25267. Epub 2024 Jan 5. |
| 37331992 | Derived | Ostergaard M, Wu J, Fallon L, Sherlock SP, Wang C, Fleishaker D, Kanik KS, Maksymowych WP. Tofacitinib Reduces Spinal Inflammation in Vertebral Bodies and Posterolateral Elements in Ankylosing Spondylitis: Results from a Phase 2 Trial. Rheumatol Ther. 2023 Aug;10(4):1001-1020. doi: 10.1007/s40744-023-00564-y. Epub 2023 Jun 18. |
| 36138330 | Derived | Cella D, Lenderking WR, Chongpinitchai P, Bushmakin AG, Dina O, Wang L, Cappelleri JC, Navarro-Compan V. Functional Assessment of Chronic Illness Therapy-Fatigue is a reliable and valid measure in patients with active ankylosing spondylitis. J Patient Rep Outcomes. 2022 Sep 23;6(1):100. doi: 10.1186/s41687-022-00508-0. |
| 28130206 | Derived | van der Heijde D, Deodhar A, Wei JC, Drescher E, Fleishaker D, Hendrikx T, Li D, Menon S, Kanik KS. Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study. Ann Rheum Dis. 2017 Aug;76(8):1340-1347. doi: 10.1136/annrheumdis-2016-210322. Epub 2017 Jan 27. |
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks. |
| FG002 | Tofacitinib 10 mg BID | Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| FG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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Safety population - included participants who received at least 1 dose of study medication
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib 2 mg BID | Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks. |
| BG001 | Tofacitinib 5 mg BID | Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks. |
| BG002 | Tofacitinib 10 mg BID | Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| BG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12 | The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing. | Full Analysis Set (FAS): included all participants who were randomized to the study and received at least one dose of the randomized study drug (Tofacitinib or placebo). | Posted | Number | Percentage of participants | Week 12 |
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| Primary | Percentage of Participants Achieving ASAS20 at Week 12 | The supportive analysis of this outcome measure was performed using the normal approximation for two proportions. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing. | FAS | Posted | Number | Percentage of participants | Baseline, Week 12 |
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| Secondary | Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8 | Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing. | FAS - n=number of responders at each visit. | Posted | Number | Percentage of participants | Baseline, Week 2, Week 4, Week 8 |
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| Secondary | Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score of the Sacroiliac (SI) Joints at Week 12 | SPARCC scoring consists of assessing six SI joint MRI image coronal slices representing the largest proportion of the synovial compartment of the SI joints for edema. The maximum score per slice was 2 and 12 for all 6 slices. The total minimum and maximum score for all SI joints across 6 slices is 0 to 72 and higher scores indicate more inflammation. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available. | FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12 | SPARCC scoring of the magnetic resonance imaging (MRI) of the spine consists of assessing six disco-vertebral units (DVU) with 3 consecutive sagittal slices at each DVU. The minimum and maximum SPARCC score for all 6 DVUs is 0 to 108, with higher scores indicating more damage. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available. | FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12 | Berlin modification of the ASspiMRI is a measure of acute lesion as determined by short-tau inversion recovery (STIR) sequences. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, were scored in a single dimension, which is represented the highest level of inflammation in that particular DVU. Total spine ASspiMRI scores can range from 0-69 with higher scores indicating more disease activity. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available. | FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 12 |
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| Secondary | Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12 | ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF. | FAS - n=number of responders at each visit. | Posted | Number | Percentage of participants | Baseline, Week 2, Week 4, Week 8, Week 12 |
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| Secondary | Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12 | ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF. | FAS - n=number of responders at each visit | Posted | Number | Percentage of participants | Baseline, Week 2, Week 4, Week 8, Week 12 |
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| Secondary | Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12 | The ASDAS(CRP) is a derived score that uses back pain, duration of morning stiffness, Patient's Global Assessment of their disease and peripheral pain/swelling. The formula used for calculating the ASDAS (CRP)is: 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity. | FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 2, Week 4, Week 8, Week 12 |
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| Secondary | Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12 | The ASDAS clinically important improvement was calculated from the ASDAS data. The ASDAS clinically important improvement is defined as change (decrease) from baseline of ≥1.1 units. Missing data were handled by NRI/LOCF. | FAS - n=number of responders at each visit | Posted | Number | Percentage of participants | Baseline, Week 2, Week 4, Week 8, Week 12 |
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| Secondary | Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12 | The ASDAS major improvement was calculated from the ASDAS data. The ASDAS major improvement was defined as change (decrease) from baseline of ≥2.0 units. Missing data were handled by NRI/LOCF. | FAS - n=number of responders at each visit | Posted | Number | Percentage of participants | Baseline, Week 2, Week 4, Week 8, Week 12 |
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| Secondary | Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12 | The ASDAS inactive disease was calculated from the ASDAS data. The ASDAS inactive disease was defined as ASDAS <1.3 units. Missing data were handled by NRI/LOCF. | FAS - n=number of responders at each visit | Posted | Number | Percentage of participants | Baseline, Week 2, Week 4, Week 8, Week 12 |
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| Secondary | Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12 | BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The final BASDAI score averages the individual assessments for a final score range of 0-10. Negative values indicate improvement. | FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 2, Week 4, Week 8, Week 12 |
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| Secondary | Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12 | BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. The final BASDAI score range from 0-10. A positive response was defined as a 50% improvement in the BASDAI from baseline. | FAS - n=number of responders at each visit | Posted | Number | Percentage of participants | Baseline, Week 2, Week 4, Week 8, Week 12 |
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| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12 | BASFI is a validated self-assessment tool that determines the degree of physical functional limitation in Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0=easy, 10=impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions with lower scores indicating better physical function. The higher the negative value the better the improvement. | FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 2, Week 4, Week 8, Week 12 |
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| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12 | BASMI is an objective measure of spinal mobility and was completed by a blinded assessor. The BASMI score is composed of 5 clinical measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. The derived score used the average of the 5 assessments on a scale of 0-10 scale with higher scores indicating more impairment of spinal mobility. BASMI was analyzed using the linear function method. The higher the negative value the better the improvement. | FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 2, Week 4, Week 8, Week 12 |
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| Secondary | Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12 | Assessment of enthesitis of 13 sites was performed in the following, 1st costochondral joint left and right, 7th costochondral joint left and right, posterior superior iliac spine left and right, anterior superior iliac spine left and right, iliac crest left and right, 5th lumbar spinous process and proximal insertion of Achilles tendon left and right. Each site was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness). | FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 4, Week 8, Week 12 |
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| Secondary | Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History | Participants were assessed at Baseline, Week 12 and Week 16 (Follow-up) to determine if they had specific Ankylosing Spondylitis medical history or changes in specific Ankylosing Spondylitis medical history which included: Inflammatory Bowel Disease (IBD), Peripheral Articular Involvement (PAI; as assessed by swollen joint count), psoriasis (PSO) and uveitis (UVE). | FAS - n=number of participants completing the Specific Medical History Assessment at each visit. | Posted | Number | Percentage of Participants | Baseline, Week 12 and Follow-up |
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| Secondary | Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12 | This assessment was performed by the blinded assessor using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints) for determination of the total number of swollen joints. Forty-four joints were assessed for swelling on left and right side and included the following: sternoclaviculars, acromioclaviculars, shoulders, elbows, wrists, metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (II, III, IV, V), knees, ankles, and metatarsophalangeals (I, II, III, IV, V). Artificial joints were not assessed. A negative change means improvement. | FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement | Posted | Least Squares Mean | Standard Error | Swollen Joints | Baseline, Week 2, Week 4, Week 8, Week 12 |
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| Secondary | Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12 | Chest expansion, measured in centimeters (cm), is defined as the difference in the thoracic circumference during full expiration versus full inspiration. This was measured at the 4th intercostal space. The difference between maximal inspiration and expiration of the two attempts was recorded. The better of the two attempts was used to calculate chest expansion. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available. | FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement | Posted | Least Squares Mean | Standard Error | cm | Baseline, Week 2, Week 4, Week 8, Week 12 |
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| Secondary | Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12 | SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=no functioning, 100=highest level of functioning). Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available. | FAS | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in EuroQol EQ-5D Health State Profile (EQ-5D) Utility Score at Week 12 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]). | FAS | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12 | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). | FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 2, Week 4, Week 8, Week 12 |
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From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tofacitinib 2 mg BID | Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks. | 0 | 52 | 15 | 52 | ||
| EG001 | Tofacitinib 5 mg BID | Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks. | 1 | 52 | 10 | 52 | ||
| EG002 | Tofacitinib 10 mg BID | Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. | 1 | 52 | 13 | 52 | ||
| EG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. | 2 | 51 | 14 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA v18.0 | Non-systematic Assessment |
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| Iridocyclitis | Eye disorders | MedDRA v18.0 | Non-systematic Assessment |
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| Tendon injury | Injury, poisoning and procedural complications | MedDRA v18.0 | Non-systematic Assessment |
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| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA v18.0 | Non-systematic Assessment |
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| Uterine spasm | Reproductive system and breast disorders | MedDRA v18.0 | Non-systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v18.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v18.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v18.0 | Non-systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA v18.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA v18.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v18.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v18.0 | Non-systematic Assessment |
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| Vaginitis bacterial | Infections and infestations | MedDRA v18.0 | Non-systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA v18.0 | Non-systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v18.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA v18.0 | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA v18.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v18.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v18.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v18.0 | Non-systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v18.0 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA v18.0 | Non-systematic Assessment |
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| Balanoposthitis | Reproductive system and breast disorders | MedDRA v18.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v18.0 | Non-systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D013166 | Spondylitis |
| D025241 | Spondylarthritis |
| D025242 | Spondylarthropathies |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C479163 | tofacitinib |
Not provided
Not provided
Not provided
| Male |
|
| Emax Model |
| Risk Difference (RD) |
| 22.9 |
| 2-Sided |
| 95 |
| 8.4 |
| 37.7 |
| No |
| Superiority or Other |
| Emax model - 95% Confidence Interval represents 95% Credible Interval | Emax Model | Risk Difference (RD) | 27.3 | 2-Sided | 95 | 10.7 | 43.4 | No | Superiority or Other |
| OG002 |
| Tofacitinib 10 mg BID |
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
|
|
|
| Tofacitinib 10 mg BID |
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
|
|
|
| Tofacitinib 10 mg BID |
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
|
|
|
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
|
|
|
| OG002 | Tofacitinib 10 mg BID | Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
|
|
|
| Placebo BID |
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
|
|
|
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
|
|
|
| Tofacitinib 10 mg BID |
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
|
|
|
| Placebo BID |
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
|
|
|
| Placebo BID |
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
|
|
|
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
|
|
|
| Tofacitinib 10 mg BID |
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
|
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Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
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Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
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Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
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Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
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| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
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| OG002 |
| Tofacitinib 10 mg BID |
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
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Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
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| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
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| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
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| Tofacitinib 10 mg BID |
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
| OG003 | Placebo BID | Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks. |
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