Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).
This was a Phase IIIb, multi-center, randomized, partially-blinded, active-controlled, parallel-group design in subjects with AS. The study consisted of a screening period (up to 10 weeks before randomization), a treatment period (104 weeks), and two follow-up visits (Weeks 112 and 120).
Subjects in both secukinumab dose groups received study treatment at baseline, Weeks 1, 2, 3 and 4 followed by treatment every 4 weeks through Week 100. Subjects in the GP2017 group received study treatment at baseline and every two weeks through Week 102. Subjects could self-administer all secukinumab / placebo and GP2017 doses at the study site or at home. Study treatment (secukinumab vs. GP2017) was provided in an open-label fashion. Subjects in the secukinumab groups were blinded to the dose (150 mg vs. 300 mg). Subjects who received rescue treatment with prohibited medications were allowed to remain in the study but had to discontinue study treatment. Subjects were treated for 104 weeks with two follow-up visits (Weeks 112 and 120).
A total of 859 subjects were randomized to treatment at 171 sites in 30 countries in Europe, North America, South America, and Asia.
.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIN457 150 mg/placebo | Experimental | AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100 |
|
| AIN457 300 mg | Experimental | AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100 |
|
| GP2017 40mg | Active Comparator | GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) | Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score <= 0.5. | Baseline and at Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set) | Radiographic changes in the spine were based on the change in score of the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) from baseline to Week 104. The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Mesa | Arizona | 85202 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33978600 | Derived | Sieper J, Poddubnyy D. Twenty years of clinical trials in axial spondyloarthritis: what can we learn for the future? Curr Opin Rheumatol. 2021 Jul 1;33(4):363-369. doi: 10.1097/BOR.0000000000000804. | |
| 31983056 | Derived | Baraliakos X, Ostergaard M, Gensler LS, Poddubnyy D, Lee EY, Kiltz U, Martin R, Sawata H, Readie A, Porter B; SURPASS Study Group. Comparison of the Effects of Secukinumab and Adalimumab Biosimilar on Radiographic Progression in Patients with Ankylosing Spondylitis: Design of a Randomized, Phase IIIb Study (SURPASS). Clin Drug Investig. 2020 Mar;40(3):269-278. doi: 10.1007/s40261-020-00886-7. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novctrd.com | View source |
Not provided
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Not provided
Not provided
Not provided
Not provided
A total of 859 subjects were randomized to treatment at 171 sites in 30 countries in Europe, North America, South America, and Asia
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AIN457 150 mg/Placebo | AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104 |
| FG001 | AIN457 300 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2021 | Nov 21, 2022 |
Not provided
Study was partially blinded. Subjects, investigators, site personnel, persons performing the assessments, monitors and the Sponsor remained blinded to the dose group of secukinumab (150 mg versus 300 mg)
Not provided
Not provided
The Participant, Care Provider, Investigator and Sponsor are blinded to Secukinumab dose
| GP2017 (adalimumab biosimilar) | Biological | 40 mg in pre-filled syringes was administered subcutaneously |
|
|
| AIN457 150 mg | Biological | 150 mg in pre-filled syringes was administered subcutaneously |
|
|
| Baseline and at Week 104 |
| Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset) | Syndesmophytes are bony growths that develop on corner of the vertebrae of the spine which are indicators of AS. A participant was considered to have a syndesmophyte if at least one reader assessed vertebral corner as >= 2 at on the mSASSS scale at baseline. Only participants with a syndesmophyte at baseline were evaluated at Week 104 for new syndesmophytes. A new syndesmophyte was a syndesmophyte present at Week 104 which was not present at baseline. Absence of new syndesmophyte was defined as having individual vertebral score < 2 on the mSASSS scale for all interpretable locations that had no syndesmophyte at baseline. Missing responses for subjects without new syndesmophyte at Week 104 were imputed by multiple imputation (MCMC). | Baseline and at Week 104 |
| Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset) | Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a minimum score of 0 and a maximum score of 24. Higher scores indicate more inflammation. | Baseline and at Week 104 |
| Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset) | Magnetic Resonance Images (MRI) of the spine were assessed for the presence and severity of bone marrow edema in the spinal vertebrae according to the Berlin modification of the ASspiMRI-a edema score with a score range of 0 to 69. Higher scores indicate more inflammation. | Baseline and at Week 104 |
| Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20) | Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity. | Week 104 |
| Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40) | Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity. | Week 104 |
| Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set) | The Assessment of SpondyloArthritis International Society (ASAS) partial remission response criteria consisted of the following assessment domains measured on visual analogue scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The ASAS partial remission criteria was defined as a value not above 2 units in each of the four domains on a scale of 10. | Week 104 |
| Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set) | The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. Parameters used for the ASDAS include spinal pain (BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive protein (CRP) in mg/L (Sieper 2009, Lukas 2009). Disease activity states are inactive disease, moderate disease activity, high disease activity, and very high disease activity. The 3 values selected to separate these states were < 1.3 between inactive disease and moderate disease activity, < 2.1 between moderate disease activity and high disease activity, and > 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change ≥ 1.1 unit for "minimal clinically important improvement" and a change ≥ 2.0 units for "major improvement" (Machado 2011). | Week 104 |
| Escondido |
| California |
| 92025 |
| United States |
| Novartis Investigative Site | La Mesa | California | 91942 | United States |
| Novartis Investigative Site | San Francisco | California | 94143 0138 | United States |
| Novartis Investigative Site | Gainesville | Florida | 32607 | United States |
| Novartis Investigative Site | Boise | Idaho | 83702 | United States |
| Novartis Investigative Site | Shreveport | Louisiana | 71101 | United States |
| Novartis Investigative Site | Wheaton | Maryland | 20902 | United States |
| Novartis Investigative Site | Great Falls | Montana | 59405 | United States |
| Novartis Investigative Site | Lincoln | Nebraska | 68516 | United States |
| Novartis Investigative Site | Greensboro | North Carolina | 27408 | United States |
| Novartis Investigative Site | Dayton | Ohio | 45402 | United States |
| Novartis Investigative Site | Middleburg Heights | Ohio | 44130 | United States |
| Novartis Investigative Site | Portland | Oregon | 97239 | United States |
| Novartis Investigative Site | Duncansville | Pennsylvania | 16635 | United States |
| Novartis Investigative Site | Memphis | Tennessee | 38119 | United States |
| Novartis Investigative Site | Mesquite | Texas | 75150 | United States |
| Novartis Investigative Site | Kennewick | Washington | 99336 | United States |
| Novartis Investigative Site | Franklin | Wisconsin | 53132 | United States |
| Novartis Investigative Site | Ciudad Autonoma de Bs As | C1428AZF | Argentina |
| Novartis Investigative Site | Malvern East | Victoria | 3145 | Australia |
| Novartis Investigative Site | Brussels | 1070 | Belgium |
| Novartis Investigative Site | Genk | 3600 | Belgium |
| Novartis Investigative Site | Winnipeg | Manitoba | R3A 1M1 | Canada |
| Novartis Investigative Site | Barrie | Ontario | L4M 6L2 | Canada |
| Novartis Investigative Site | Québec | Quebec | G1V 3M7 | Canada |
| Novartis Investigative Site | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Novartis Investigative Site | Santiago | RM | 7500588 | Chile |
| Novartis Investigative Site | Concepción | Chile |
| Novartis Investigative Site | Santiago | 8207257 | Chile |
| Novartis Investigative Site | Santiago | Chile |
| Novartis Investigative Site | Bucaramanga | Santander Department | 0001 | Colombia |
| Novartis Investigative Site | Barranquilla | 080020 | Colombia |
| Novartis Investigative Site | Brno-Zidonice | CZE | 61500 | Czechia |
| Novartis Investigative Site | Brno | 63800 | Czechia |
| Novartis Investigative Site | Prague | 128 50 | Czechia |
| Novartis Investigative Site | Prague | 14900 | Czechia |
| Novartis Investigative Site | Uherské Hradiště | 686 01 | Czechia |
| Novartis Investigative Site | Aalborg | DK 9000 | Denmark |
| Novartis Investigative Site | Copenhagen | 2100 | Denmark |
| Novartis Investigative Site | Joensuu | 80210 | Finland |
| Novartis Investigative Site | Nice | Cedex1 | 06001 | France |
| Novartis Investigative Site | Boulogne-Billancourt | 92104 | France |
| Novartis Investigative Site | Le Mans | 72037 | France |
| Novartis Investigative Site | Monaco | 98000 | France |
| Novartis Investigative Site | Paris | 75012 | France |
| Novartis Investigative Site | Paris | 75679 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Bad Doberan | 18209 | Germany |
| Novartis Investigative Site | Bayreuth | 95444 | Germany |
| Novartis Investigative Site | Berlin | 12163 | Germany |
| Novartis Investigative Site | Berlin | 13125 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Berlin | 14059 | Germany |
| Novartis Investigative Site | Chemnitz | 09130 | Germany |
| Novartis Investigative Site | Erlangen | 91056 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Hamburg | 20095 | Germany |
| Novartis Investigative Site | Hamburg | 22415 | Germany |
| Novartis Investigative Site | Herne | 44649 | Germany |
| Novartis Investigative Site | Magdeburg | 39110 | Germany |
| Novartis Investigative Site | Planegg | 82152 | Germany |
| Novartis Investigative Site | Ratingen | 40878 | Germany |
| Novartis Investigative Site | Thessaloniki | GR | 564 29 | Greece |
| Novartis Investigative Site | Athens | 115 27 | Greece |
| Novartis Investigative Site | Athens | 145 61 | Greece |
| Novartis Investigative Site | Haifa | 3109601 | Israel |
| Novartis Investigative Site | Haifa | 3339419 | Israel |
| Novartis Investigative Site | Tel Aviv | 6423906 | Israel |
| Novartis Investigative Site | Nishinomiya | Hyōgo | 663 8501 | Japan |
| Novartis Investigative Site | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| Novartis Investigative Site | Nankoku | Kochi | 783 8505 | Japan |
| Novartis Investigative Site | Tenri | Nara | 632-8552 | Japan |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | 113-8431 | Japan |
| Novartis Investigative Site | Chuo Ku | Tokyo | 104-8560 | Japan |
| Novartis Investigative Site | Meguro City | Tokyo | 153-8515 | Japan |
| Novartis Investigative Site | Shinjuku-ku | Tokyo | 160 8582 | Japan |
| Novartis Investigative Site | Torreón | Coahulia | 27000 | Mexico |
| Novartis Investigative Site | Mexicali | Estado de Baja California | 21100 | Mexico |
| Novartis Investigative Site | Monterrey | Nuevo León | 64460 | Mexico |
| Novartis Investigative Site | Culiacan | State of Mexico | 80000 | Mexico |
| Novartis Investigative Site | San Luis Potosí City | 78213 | Mexico |
| Novartis Investigative Site | Leiden | South Holland | 2333 ZA | Netherlands |
| Novartis Investigative Site | Amsterdam | 1105 AZ | Netherlands |
| Novartis Investigative Site | Leeuwarden | 8934 AD | Netherlands |
| Novartis Investigative Site | Maastricht | 6229 HX | Netherlands |
| Novartis Investigative Site | Rotterdam | 3079 DZ | Netherlands |
| Novartis Investigative Site | Jesus Maria | Lima region | 11 | Peru |
| Novartis Investigative Site | San Isidro | Lima region | 27 | Peru |
| Novartis Investigative Site | Santiago de Surco | Lima region | 33 | Peru |
| Novartis Investigative Site | Lima | 1 | Peru |
| Novartis Investigative Site | Manila | 1008 | Philippines |
| Novartis Investigative Site | Quezon City | 1102 | Philippines |
| Novartis Investigative Site | Quezon City | 1118 | Philippines |
| Novartis Investigative Site | Bydgoszcz | 85 168 | Poland |
| Novartis Investigative Site | Dopiewo | 62 069 | Poland |
| Novartis Investigative Site | Krakow | 30 002 | Poland |
| Novartis Investigative Site | Poznan | 61 113 | Poland |
| Novartis Investigative Site | Sopot | 81 756 | Poland |
| Novartis Investigative Site | Almada | 2801 951 | Portugal |
| Novartis Investigative Site | Lisbon | 1050-034 | Portugal |
| Novartis Investigative Site | Lisbon | 1349 019 | Portugal |
| Novartis Investigative Site | Ponte de Lima | 4990 041 | Portugal |
| Novartis Investigative Site | Porto | 4200 319 | Portugal |
| Novartis Investigative Site | Vila Nova de Gaia | 4434 502 | Portugal |
| Novartis Investigative Site | Bucharest | 011172 | Romania |
| Novartis Investigative Site | Bucharest | 030167 | Romania |
| Novartis Investigative Site | Cluj-Napoca | 400006 | Romania |
| Novartis Investigative Site | Barnaul | 656050 | Russia |
| Novartis Investigative Site | Chelyabinsk | 454076 | Russia |
| Novartis Investigative Site | Ivanovo | 153005 | Russia |
| Novartis Investigative Site | Kazan' | 420097 | Russia |
| Novartis Investigative Site | Kemerovo | 650029 | Russia |
| Novartis Investigative Site | Kemerovo | 650066 | Russia |
| Novartis Investigative Site | Moscow | 115522 | Russia |
| Novartis Investigative Site | Moscow | 129110 | Russia |
| Novartis Investigative Site | Petrozavodsk | 185019 | Russia |
| Novartis Investigative Site | Saint Petersburg | 190068 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197022 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197341 | Russia |
| Novartis Investigative Site | Ufa | 450005 | Russia |
| Novartis Investigative Site | Yaroslavl | 150003 | Russia |
| Novartis Investigative Site | Yekaterinburg | 620137 | Russia |
| Novartis Investigative Site | Bratislava | Slovak Republic | 813 69 | Slovakia |
| Novartis Investigative Site | Piešťany | SVK | 921 12 | Slovakia |
| Novartis Investigative Site | Bratislava | 85101 | Slovakia |
| Novartis Investigative Site | Košice | 04011 | Slovakia |
| Novartis Investigative Site | Stará Ľubovňa | 06401 | Slovakia |
| Novartis Investigative Site | Seoul | Seocho Gu | 06591 | South Korea |
| Novartis Investigative Site | Gwangju | 61469 | South Korea |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Seoul | 04763 | South Korea |
| Novartis Investigative Site | Seoul | 05278 | South Korea |
| Novartis Investigative Site | Seoul | 06273 | South Korea |
| Novartis Investigative Site | Villajoyosa | Alicante | 703570 | Spain |
| Novartis Investigative Site | Bilbao | Basque Country | 48013 | Spain |
| Novartis Investigative Site | San Vicente de Barakaldo | Bizkaia | 48903 | Spain |
| Novartis Investigative Site | Santander | Cantabria | 39008 | Spain |
| Novartis Investigative Site | Badalona | Catalonia | 08916 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08003 | Spain |
| Novartis Investigative Site | A Coruña | Galicia | 15006 | Spain |
| Novartis Investigative Site | Santiago de Compostela | Galicia | 15706 | Spain |
| Novartis Investigative Site | Vigo | Pontevedra | 36200 | Spain |
| Novartis Investigative Site | Vitoria-Gasteiz | Vitoria Gasteiz | 01009 | Spain |
| Novartis Investigative Site | Madrid | 28942 | Spain |
| Novartis Investigative Site | Valencia | 46009 | Spain |
| Novartis Investigative Site | Taichung | Taiwan ROC | 40201 | Taiwan |
| Novartis Investigative Site | Dalin | 622 | Taiwan |
| Novartis Investigative Site | Kaohsiung City | 80756 | Taiwan |
| Novartis Investigative Site | Kaohsiung City | 81346 | Taiwan |
| Novartis Investigative Site | Taipei | 10048 | Taiwan |
| Novartis Investigative Site | Istanbul | TUR | 34098 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06230 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06560 | Turkey (Türkiye) |
| Novartis Investigative Site | Eskişehir | 26040 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35340 | Turkey (Türkiye) |
| Novartis Investigative Site | Kocaeli | 41380 | Turkey (Türkiye) |
| Novartis Investigative Site | Christchurch | Dorset | BH23 2JX | United Kingdom |
| Novartis Investigative Site | London | Edmonton | N18 1QX | United Kingdom |
| Novartis Investigative Site | London | GBR | SW10 9NH | United Kingdom |
| Novartis Investigative Site | Portsmouth | Hants | PO6 3LY | United Kingdom |
| Novartis Investigative Site | Leytonstone | London | E11 1NR | United Kingdom |
| Novartis Investigative Site | Stoke-on-Trent | Staffordshire | ST6 7AG | United Kingdom |
| Novartis Investigative Site | Bath | BA1 3NG | United Kingdom |
| Novartis Investigative Site | Bristol | BS1 3NU | United Kingdom |
| Novartis Investigative Site | Leicester | LE1 5WW | United Kingdom |
| Novartis Investigative Site | Liverpool | L9 7AL | United Kingdom |
| Novartis Investigative Site | London | NW3 2QG | United Kingdom |
| Novartis Investigative Site | Norwich | NR4 7UY | United Kingdom |
| Novartis Investigative Site | Torquay | TQ2 7AA | United Kingdom |
| Novartis Investigative Site | Wolverhampton | WV10 0QP | United Kingdom |
AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104
| FG002 | GP2017 40mg | GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AIN457 150 mg/Placebo | AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104 |
| BG001 | AIN457 300 mg | AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104 |
| BG002 | GP2017 40mg | GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| |||||||||||
| Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) scores | The modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) evaluates the outside corners of the vertebral spine for erosions, sclerosis, squaring, bony growths and spinal bridging. The mSASSS assesses the participant's spinal vertebrae for structural changes and scores each vertebrae from 0 (normal vertebrae) to 3 (bony growth that bridges one vertebrae to the neighboring vertebrae). A total of 24 vertebral corners are scored for a possible maximum grade of 72. | The baseline mSASSS was determined only from those participants who provided evaluable baseline X-ray images. | Mean | Standard Deviation | score on a scale |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) | Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score <= 0.5. | Full analysis set | Posted | Number | Percentage of participants | Baseline and at Week 104 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set) | Radiographic changes in the spine were based on the change in score of the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) from baseline to Week 104. The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. | Full analysis set | Posted | Least Squares Mean | Standard Error | mSASSS scores | Baseline and at Week 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset) | Syndesmophytes are bony growths that develop on corner of the vertebrae of the spine which are indicators of AS. A participant was considered to have a syndesmophyte if at least one reader assessed vertebral corner as >= 2 at on the mSASSS scale at baseline. Only participants with a syndesmophyte at baseline were evaluated at Week 104 for new syndesmophytes. A new syndesmophyte was a syndesmophyte present at Week 104 which was not present at baseline. Absence of new syndesmophyte was defined as having individual vertebral score < 2 on the mSASSS scale for all interpretable locations that had no syndesmophyte at baseline. Missing responses for subjects without new syndesmophyte at Week 104 were imputed by multiple imputation (MCMC). | Syndesmophyte subset only included participants who had a syndesmophyte at baseline as measured on the mSASSS scale. | Posted | Number | Percentage of participants | Baseline and at Week 104 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset) | Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a minimum score of 0 and a maximum score of 24. Higher scores indicate more inflammation. | MRI subset only included participants who had an MRI performed at selected centers | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and at Week 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset) | Magnetic Resonance Images (MRI) of the spine were assessed for the presence and severity of bone marrow edema in the spinal vertebrae according to the Berlin modification of the ASspiMRI-a edema score with a score range of 0 to 69. Higher scores indicate more inflammation. | MRI subset only included participants who had an MRI performed at selected centers | Posted | Least Squares Mean | Standard Error | Berlin mod. of ASspiMRI-a edema scores | Baseline and at Week 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20) | Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity. | Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40) | Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity. | Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set) | The Assessment of SpondyloArthritis International Society (ASAS) partial remission response criteria consisted of the following assessment domains measured on visual analogue scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The ASAS partial remission criteria was defined as a value not above 2 units in each of the four domains on a scale of 10. | Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms. | Posted | Number | 95% Confidence Interval | Percentage participants | Week 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set) | The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. Parameters used for the ASDAS include spinal pain (BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive protein (CRP) in mg/L (Sieper 2009, Lukas 2009). Disease activity states are inactive disease, moderate disease activity, high disease activity, and very high disease activity. The 3 values selected to separate these states were < 1.3 between inactive disease and moderate disease activity, < 2.1 between moderate disease activity and high disease activity, and > 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change ≥ 1.1 unit for "minimal clinically important improvement" and a change ≥ 2.0 units for "major improvement" (Machado 2011). | Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 104 |
|
Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.
Not provided
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 | AIN457 150 mg/Placebo | AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104 | 1 | 286 | 40 | 286 | 106 | 286 |
| EG001 | AIN457 300 mg | AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104 | 1 | 285 | 29 | 285 | 107 | 285 |
| EG002 | GP2017 40 mg | GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104 | 3 | 285 | 32 | 285 | 99 | 285 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Chronic gastrointestinal bleeding | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Gastroenteritis eosinophilic | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Ileal ulcer | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Medical device pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Immunosuppression | Immune system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Myelitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Chloroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Brain hypoxia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Lacunar stroke | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (25.0) | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA (25.0) | Systematic Assessment |
| |
| Device issue | Product Issues | MedDRA (25.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Micturition disorder | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Iliac artery stenosis | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | +1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2022 | Nov 21, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
Not provided
Not provided
| ID | Term |
|---|---|
| C000630858 | GP2017 |
| C000712789 | adalimumab biosimilar HS016 |
| C555450 | secukinumab |
Not provided
Not provided
Not provided
|
|
|
| Black or African American |
|
|
| Asian |
|
|
| American Indian or Alaska Native |
|
|
| Other |
|
|
| Multiple |
|
|
|
Logistic regression model with treatment as a factor and baseline mSASSS score as a covariate using marginal standardization method. |
| 0.6925 |
| Marginal difference |
| 1.67 |
| 2-Sided |
| 95 |
| -6.61 |
| 9.95 |
| Superiority |
|
|
|
| OG002 | GP2017 40mg | GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 104 |
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 104 |
|
|
|