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2. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial

Author

Morin, Frederic, Rahman, Proton, Ariel, Federico, Berman, Alberto, Carrio, Judith, Lucero, Eleonora, Cocco, Jose Maldonado, Hidalgo, Rodolfo Pardo, Velasco, Jorge, Viola, Diego O., Grisar, Johannes, Resch, Heinrich, Scheinecker, Clemens, Melazzi, Ana Claudia, Roimicher, Luis, Scotton, Antonio Scafuto, Rodriguez, Aaron Alejandro Barrera, Molina, Francisco Fidencio Cons, Barragan, Sergio Duran, Skinner, Cassandra M., Tena, Cesar Francisco Pacheco, Remus, Cesar Ricardo Ramos, Rodriguez, Juan Cruz Rizo, Hong, Seung-Jae, Kang, Seong Wook, Lee, Chang Keun, Lee, Eun Bong, Lee, Sang Heon, Park, Min-Chan, Lee, Sang-Hoon, Dokoupilova, Eva, Dvorak, Zdenek, Malcova, Martina, Pvelka, Karel, Eklund, Kari K., Jarvinen, Pentti, Karjalainen, Anna, Paimela, Leena, Taniguchi, Yoshinori, Tsuda, Tokutaro, Tada, Kurisu, Dobashi, Hiroaki, Inui, Kentaro, Ueki, Yukitaka, Matsumoto, Yoshifuji, Hatta, Kazuhiro, Atsumi, Tatsuya, Goto, Hitoshi, Honjo, Shigeru, Matsui, Kiyoshi, Takakubo, Yuya, Neeck, Gunther, Wagner, Sylke, Braun, Jürgen, Blicharshi, Tomasz, Dudek, Anna, Hrycai, Pawel, Plebanski, Rafal, Drabiszcak-Piatkowska, Janina, Brzezicki, Jan, Krogulec, Marek, Opris-Belinski, Daniela, Ramazan, Ana Maria, Tronaru, Luminita, van de Sande, Marleen G., Matsievskaya, Galina, Schmidt, Evgeniya, Stanislav, Marina, Yakushin, Sergey, Ershova, Olga, Rebroy, Andrey, Churchill, Melvin A., Flint, Kathleen P., Greenwald, Maria, Howell, Mary P., Kaine, Jeffrey L., Kivitz, Alan, Klein, Steven J., Mueller, Eric C., Peters, Eric A., Querubin, Roel, Sayers, Michael E., Scoville, Craig D., Shanahan, Joseph C., Roseff, Richard, Hull, John E., Mallepalli, Jyothi R., Sebai, Mohamed B., Kimmel, Steven C., Goddard, David H., Mease, Philip J., Harris, Mark D., Mabaquiao, Arthur R., Diegel, Roger J., Thai, Christine, Rivera, Tania L., Perez-De Jesus, Amarilis, Soto-Raices, Oscar, Toro-Torres, Ramon, Pantojas, Carlos, Deodhar, Atul, van der Heijde, Désirée, Gensler, Lianne S, Kim, Tae-Hwan, Maksymowych, Walter P, Østergaard, Mikkel, Poddubnyy, Denis, Marzo-Ortega, Helena, Bessette, Louis, Tomita, Tetsuya, Leung, Ann, Hojnik, Maja, Gallo, Gaia, Li, Xiaoqi, Adams, David, Carlier, Hilde, and Sieper, Joachim

Published
2020
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3. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial

Author

Churchill, Melvin, Flint, Kathleen, Gladstein, Geoffrey, Greenwald, Maria, Howell, Mary, Ince, Akgun, Kaine, Jeffrey, Mehta, Daksha, Peters, Eric, Querubin, Roel, Reveille, John, Roseff, Richard, Diegel, Roger, Thai, Christine, Bessette, Louis, Morin, Frederic, Rahman, Proton, Barrera Rodriguez, Aaron Alejandro, Cons-Molina, Fidencio, Duran Barragan, Sergio, Skinner, Cassandra, Pacheco Tena, Cesar, Ramos Remus, Cesar, Rizo Rodriguez, Juan Cruz, Hong, Seung-Jae, Lee, Yeon-Ah, Ju, Ji Hyeon, Kang, Seong Wook, Kim, Tae-Hwan, Lee, Chang Keun, Lee, Eun Bong, Lee, Sang Heon, Park, Min-Chan, Shin, Kichul, Lee, Sang-Hoon, Chen, Hung-An, Chen, Ying-Chou, Hsieh, Song-Chou, Lan, Joung-Liang, Dvorak, Zdenek, Moravcova, Radka, Malcova, Martina, Taniguchi, Yoshinori, Kishimoto, Mitsumasa, Tada, Kurisu, Dobashi, Hiroaki, Inui, Kentaro, Ueki, Yukitaka, Matsumoto, Yoshifuji, Koyama, Yoshinobu, Hatta, Kazuhiro, Atsumi, Tatsuya, Goto, Hitoshi, Matsui, Kiyoshi, Takakubo, Yuya, Neeck, Gunther, Poddubnyy, Denis, Rubbert-Roth, Andrea, Szymanska, Malgorzata, Blicharski, Tomasz, Dudek, Anna, Racewicz, Artur, Wojciechowski, Rafal, van de Sande, Marleen, Griep, Ed, Nurmohamed, Mike, Matsievskaya, Galina, Shmidt, Evgeniya, Stanislav, Marina, Yakushin, Sergey, Ershova, Olga, Rebrov, Andrey, Balazs, Tibor, Cseuz, Regina, Drescher, Edit, Poor, Gyula, van der Heijde, Désirée, Cheng-Chung Wei, James, Dougados, Maxime, Mease, Philip, Deodhar, Atul, Maksymowych, Walter P, Van den Bosch, Filip, Sieper, Joachim, Tomita, Tetsuya, Landewé, Robert, Zhao, Fangyi, Krishnan, Eswar, Adams, David H., Pangallo, Beth, and Carlier, Hilde

Published
2018
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4. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial

Author

Ahmed, Khalid, Alper, Jeffrey, Barkham, Nichol, Bennett, Ralph E., García, Francisco Javier Blanco, Alonso, Ricardo Blanco, Blumstein, Howard B., Brooks, Michael S., Burmester, Gerd-Rüdiger, Cagnoli, Patricia, Caldron, Paul H., Cantagrel, Alain, Chen, Der-Yuan, Churchill, Melvin A., Jr, Codding, Christine E., Combe, Benard, Deane, Peter M.G., Del Giudice, Jose, Deodhar, Atul A., Dhar, Rajat K., Dokoupilova, Eva, Egan, Rita M., Everding, Andrea, Galíndez, Eva, Genovese, Mark, Goddard, David H., Gottlieb, Alice, Goupille, Philippe, Griffin, Robert M., Gupta, Ramesh C., Hall, Stephen, Hatti, Kalpita, Howell, Mary P., Huang, Yu-Huei, Jajoo, Ramina, Janssen, Namieta M., Kiltz, Uta, Kivitz, Alan J., Klein, Steven J., Korkosz, Mariusz P., Kotha, Roshan, Kremer, Joel M., Lue, Cummins, de la Fuente, José Luis Marenco, Marzo-Ortega, Helena, Masmitja, Jordi Gratacós, Mease, Philip J., Meroni, Pier Luigi, Mueller, Eric C., Nandagudi, Anupama C., Nash, Peter, Fernández-Nebro, Antonio, Neuwelt, Clark M., Orbai, Ana Maria, Oza, Meera R., Parks, Deborah L., Pattanaik, Debendra, Rell-Bakalarska, Maria E., Rosmarin, David, Roussou, Euthalia, Rychlewska-Hanczewksa, Anna I., Sikes, David H., Stack, Michael T., Sunkureddi, Prashanth, Tahir, Hasan, Thaçi, Diamant, Tsai, Tsen-Fang, Turkiewicz, Anthony M., Unger, Leonore, Cabello, Raúl Veiga, Wagner, Ulf, Wei, Cheng-Chung, Wells, Alvin F., Youssef, Peter, Zielinska, Agnieszka, Kirkham, Bruce, Okada, Masato, Rahman, Proton, Burmester, Gerd-Ruediger, Adams, David H, Kerr, Lisa, Lee, Chin, and Shuler, Catherine L

Published
2017
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7. Golimumab, A Human Anti-Tumor Necrosis Factor α Monoclonal Antibody, Injected Subcutaneously Every Four Weeks in Methotrexate-naive Patients With Active Rheumatoid Arthritis: Twenty-four-Week Results of A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Golimumab Before Methotrexate as First-line Therapy for Early-onset Rheumatoid Arthritis

Author

Emery, Paul, Fleischmann, Roy M., Moreland, Larry W., Hsia, Elizabeth C., Strusberg, Ingrid, Durez, Patrick, Nash, Peter, Amante, Eric Jason B., Churchill, Melvin, Park, Won, Pons-Estel, Bernardo Antonio, Doyle, Mittie K., Visvanathan, Sudha, Xu, Weichun, and Rahman, Mahboob U.

Published
2009
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8. Treatment of Rheumatoid Arthritis With Methotrexate and Hydroxychloroquine, Methotrexate and Sulfasalazine, or a Combination of the Three Medications: Results of a Two-Year, Randomized, Double-Blind, Placebo-Controlled Trial

Author

OʼDell, James R., Leff, Robert, Paulsen, Gail, Haire, Claire, Mallek, Jack, Eckhoff, James P., Fernandez, Ana, Blakely, Kent, Wees, Steven, Stoner, Julie, Hadley, Stephen, Felt, Jeffrey, Palmer, William, Waytz, Paul, Churchill, Melvin, Klassen, Lynell, and Moore, Gerald

Published
2002
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11. Efficacy and Safety of Intravenous Secukinumab for the Treatment of Active Psoriatic Arthritis: Results From a Randomized, Placebo‐Controlled Phase 3 Study.

Author

Kivitz, Alan, Sedova, Liliana, Churchill, Melvin, Kotha, Roshan, Singhal, Atul, Torres, Alexander, Valenzuela, Guillermo, Whelan, Sarah, Dumortier, Thomas, Zhu, Xuan, Martin, Ruvie, and Pricop, Luminita

Abstract

Objective Methods Results Conclusion The aim of this study was to evaluate the efficacy and safety of intravenous (IV) secukinumab in patients with active psoriatic arthritis (PsA).INVIGORATE‐2 (NCT04209205) was a randomized, placebo‐controlled, phase 3 trial. Patients with active PsA were randomized 1:1 to receive IV secukinumab (6 mg/kg at baseline followed by 3 mg/kg every four weeks [q4w]) or placebo. At week 16, patients randomized to placebo were switched to IV secukinumab (3 mg/kg q4w), and patients who received IV secukinumab continued treatment through week 52. The primary efficacy endpoint was achievement of 50% improvement in American College of Rheumatology response criteria (ACR50) at week 16. Efficacy and safety were evaluated through weeks 52 and 60, respectively.Among 191 patients randomized to IV secukinumab and 190 to placebo/IV secukinumab, 177 (92.7%) and 170 (89.5%) completed the entire study period, respectively. A significantly higher proportion of patients who received IV secukinumab versus placebo achieved ACR50 at week 16 (31.4% vs 6.3%; adjusted P < 0.0001). All secondary efficacy endpoints were met at week 16 (all adjusted P < 0.05 using the predefined hypothesis‐testing hierarchy). Patients who switched from placebo to secukinumab at week 16 showed rapid improvements in ACR50 rates; by week 52, both treatment arms experienced similar improvements in efficacy outcomes. No new or unexpected safety signals were observed with receiving IV secukinumab. One death was reported in the placebo group before week 16.IV secukinumab led to rapid and sustained improvements in clinical measures of PsA, and the safety profile was consistent with that of secukinumab administered subcutaneously. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Efficacy and Safety of Subcutaneous Golimumab in Methotrexate-Naive Patients With Rheumatoid Arthritis: Five-Year Results of a Randomized Clinical Trial.

Author

Emery, Paul, Fleischmann, Roy M., Strusberg, Ingrid, Durez, Patrick, Nash, Peter, Amante, Eric Jason B., Churchill, Melvin, Park, Won, Pons-Estel, Bernardo, Han, Chenglong, Gathany, Timothy A., Xu, Stephen, Zhou, Yiying, Leu, Jocelyn H., and Hsia, Elizabeth C.

Subjects
SUBCUTANEOUS injections, ANTIRHEUMATIC agents, COMBINATION drug therapy, COMPARATIVE studies, LONGITUDINAL method, RESEARCH methodology, MEDICAL cooperation, METHOTREXATE, MONOCLONAL antibodies, RESEARCH, RHEUMATOID arthritis, EVALUATION research, RANDOMIZED controlled trials, TREATMENT effectiveness, BLIND experiment
Abstract

Objective: To evaluate the safety and efficacy of golimumab through 5 years in adults with active rheumatoid arthritis (RA) who had not previously received methotrexate (MTX).Methods: In the GO-BEFORE study, 637 MTX-naive adult patients with active RA were randomized (1:1:1:1) to placebo + MTX (group 1), golimumab 100 mg + placebo (group 2), golimumab 50 mg + MTX (group 3), or golimumab 100 mg + MTX (group 4). Inadequate responders in groups 1, 2, and 3 entered early escape at week 28 to golimumab 50 mg + MTX, golimumab 100 mg + MTX, or golimumab 100 mg + MTX, respectively; remaining patients in group 1 could cross over to golimumab 50 mg + MTX at week 52. Assessments included the American College of Rheumatology 20%/50%/70% improvement criteria (ACR20/50/70) response, the Disease Activity Score in 28 joints (DAS28) using C-reactive protein (CRP) level, and the modified Sharp/van der Heijde score (SHS). Efficacy was analyzed using an intent-to-treat (ITT) analysis. Pharmacokinetics and immunogenicity were evaluated at selected visits.Results: A total of 422 patients completed golimumab treatment through week 256. At week 256, 72.8%, 54.6%, and 38.0% of all patients in the full ITT population (n = 637) had an ACR20/50/70 response, respectively; 84.1% had a good or moderate DAS28-CRP response; and 72.7% had a clinically meaningful improvement in physical function. Radiographic progression was minimal in all treatment groups through week 256, and the overall mean change from baseline in SHS was 1.36. Serum trough golimumab concentrations were approximately dose proportional and maintained through week 256. Antibodies to golimumab occurred in 9.6% of patients through week 256. Infections were the most common type of adverse event (AE); 204 of 616 patients (33.1%) had ≥1 serious AE.Conclusion: Clinical efficacy with golimumab treatment was maintained through week 256 of the GO-BEFORE trial of MTX-naive RA patients. No unexpected AEs occurred; safety results through 5 years are consistent with earlier reports. [ABSTRACT FROM AUTHOR]

Published
2016
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13. A Randomized Clinical Trial to Evaluate Two Doses of an Intra-Articular Injection of LMWF-5A in Adults with Pain Due to Osteoarthritis of the Knee.

Author

Bar-Or, David, Salottolo, Kristin M., Loose, Holli, Phillips, Matthew J., McGrath, Brian, Wei, Nathan, Borders, James L., Ervin, John E., Kivitz, Alan, Hermann, Mark, Shlotzhauer, Tammi, Churchill, Melvin, Slappey, Donald, and Clift, Vaughan

Subjects
KNEE pain, OSTEOARTHRITIS treatment, CLINICAL trials, MOLECULAR weights, SERUM albumin, DRUG side effects, ORTHOPEDIC surgery, THERAPEUTICS
Abstract

Objective: The Low Molecular Weight Fraction of 5% human serum Albumin (LMWF-5A) is being investigated as a treatment for knee pain from osteoarthritis. Methods: This was a multicenter randomized, vehicle-controlled, double-blind, parallel study designed to evaluate the safety and efficacy of two doses of an intra-articular injection of LMWF-5A. Patients with symptomatic knee osteoarthritis were randomized 1∶1∶1∶1 to receive a single 4 mL or 10 mL intra-articular knee injection of either LMWF-5A or vehicle control (saline). The primary efficacy endpoint was the difference between treatment groups in the Western Ontario and McMaster Universities (WOMAC) pain change from baseline over 12 weeks. Safety was examined as the incidence and severity of adverse events (AEs). Results: A total of 329 patients were randomized and received treatment. LMWF-5A resulted in a significant decrease in pain at 12 weeks compared to vehicle control (−0.93 vs −0.72; estimated difference from control: −0.25, p = 0.004); an injection volume effect was not observed (p = 0.64). The effect of LMWF-5A on pain was even more pronounced in patients with severe knee OA (Kellgren Lawrence Grade IV): the estimated difference from control was −0.42 (p = 0.02). Adverse events were generally mild and were similar in patients who received vehicle control (47%) and LMWF-5A (41%). Conclusions: This clinical trial demonstrated that LMWF-5A is safe and effective at providing relief for the pain of moderate to severe OA of the knee over 12 weeks when administered by intra-articular injection into the knee. Trial Registration: ClinicalTrials.gov NCT01839331 [ABSTRACT FROM AUTHOR]

Published
2014
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14. A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-interleukin 17 receptor (IL-17R) antibody, in methotrexateresistant rheumatoid arthritis.

Author

Martin, David A., Churchill, Melvin, Flores-Suarez, Luis Felipe, Cardiel, Mario H., Wallace, Daniel, Martin, Richard, Phillips, Kristine, Kaine, Jeffrey L., Hua Dong, Salinger, David, Stevens, Erin, Russell, Chris B., and Chung, James B.

Published
2013
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15. Golimumab, a human anti–tumor necrosis factor monoclonal antibody, injected subcutaneously every 4 weeks in patients with active rheumatoid arthritis who had never taken methotrexate: 1-year and 2-year clinical, radiologic, and physical function findings of a phase III, multicenter, randomized, double-blind, placebo-controlled study.

Author

Emery, Paul, Fleischmann, Roy M, Doyle, Mittie K, Strusberg, Ingrid, Durez, Patrick, Nash, Peter, Amante, Eric, Churchill, Melvin, Park, Won, Pons-Estel, Bernardo, Xu, Weichun, Xu, Stephen, Wu, Zhong, and Hsia, Elizabeth C

Abstract

Objective: To assess 2-year golimumab efficacy/safety in patients with active rheumatoid arthritis (RA) who had never taken methotrexate (MTX).Methods: RA patients who had never taken MTX (n = 637) were randomized (1:1:1:1) to placebo + MTX (group 1), golimumab 100 mg + placebo (group 2), golimumab 50 mg + MTX (group 3), or golimumab 100 mg + MTX (group 4) every 4 weeks. Nonresponders based on week 28 swollen/tender joint counts changed treatment as follows: group 1 added golimumab 50 mg, group 2 added MTX, group 3 increased golimumab to 100 mg, and group 4 had no change. Most group 1 patients (85%) initiated golimumab 50 mg + MTX at week 28 or subsequently at week 52. After the last patient completed week 52 and blinding was broken, the investigator could escalate golimumab to 100 mg and/or adjust MTX. The co–primary end points (week 24 American College of Rheumatology criteria for 50% improvement [ACR50] response and week 52 change in Sharp/van der Heijde score [SHS]) have been published previously. We now detail week 52 major secondary end points (Health Assessment Questionnaire [HAQ] disability index [DI] scores and SHS among patients with a baseline C-reactive protein [CRP] level >1.0 mg/dl) and week 104 findings.Results: At week 52 for combined groups 3 and 4 versus group 1, the respective proportions of patients achieving ACR20 and ACR50 responses were 63.2% versus 51.9% (P = 0.017) and 45.3% versus 35.6% (P = 0.044). Respective week 52 mean HAQ DI improvements were 0.70 versus 0.58 (P = 0.053); mean SHS changes were 0.41 versus 1.37 (P = 0.006) among all patients and 0.74 versus 2.16 (P = 0.003) in patients with a CRP level >1.0 mg/dl. Improvements were maintained through week 104. Golimumab + MTX for 2 years yielded statistically less radiographic progression than initial MTX or golimumab 100 mg monotherapy. Golimumab safety profiles through weeks 24, 52, and 104 were generally consistent with those observed in other golimumab studies.Conclusion: In RA patients who had never taken MTX, up to 2 years of golimumab + MTX yielded sustained improvements in clinical signs/symptoms, physical function, and radiographic progression. [ABSTRACT FROM AUTHOR]

Published
2013
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16. Golimumab, a Human Anti-Tumor Necrosis Factor a Monoclonal Antibody, Injected Subcutaneously Every Four Weeks in Methotrexate-Naive Patients With Active Rheumatoid Arthritis: Twenty-Four-Week Results of a Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Golimumab Before Methotrexate as First-Line Therapy for Early-Onset Rheumatoid Arthritis

Author

Emery, Paul, Fleischmann, Roy M., Moreland, Larry W., Hsia, Elizabeth C., Strusberg, Ingrid, Durez, Patrick, Nash, Peter, Amante, Eric Jason B., Churchill, Melvin, Park, Won, Pons-Estel, Bernardo Antonio, Doyle, Mittie K., Visvanathan, Sudha, Xu, Weichun, and Rahman, Mahboob U.

Subjects
MONOCLONAL antibodies, RHEUMATOID arthritis, METHOTREXATE, SUBCUTANEOUS injections, SYMPTOMS, PATIENTS
Abstract

The article presents a study which evaluates the safety and effectiveness of golimumab monoclonal antibody in methotrexate (MTX) -naive patients with rheumatoid arthritis (RA). In this study, subcutaneous injections of golimumab were administered to MTX-naive patients with RA every 4 weeks. Results reveal that golimumab effectively reduces the symptoms of RA in methotrexate (MTX)-naive patients.

Published
2009
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17. Treatment of rheumatoid arthritis with methotrexate and hydroxychloroquine, methotrexate and sulfasalazine, or a combination of the three medications: Results of a two-year, randomized, double-blind, placebo-controlled trial.

Author

O'Dell, James R., Leff, Robert, Paulsen, Gail, Haire, Claire, Mallek, Jack, Eckhoff, P. James, Fernandez, Ana, Blakely, Kent, Wees, Steven, Stoner, Julie, Hadley, Stephen, Felt, Jeffrey, Palmer, William, Waytz, Paul, Churchill, Melvin, Klassen, Lynell, and Moore, Gerald

Published
2002
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