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Can a Two-Drug combo stop early rheumatoid arthritis in its tracks?

NCT ID NCT01519791

Disease control Sponsor: UCB Pharma SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial is testing whether combining certolizumab pegol, an injectable biologic, with methotrexate, a standard oral medication, can help adults with early active rheumatoid arthritis achieve and maintain remission. Participants are newly diagnosed, have not yet taken disease-modifying drugs, and will receive either the combination or a placebo over about a year. The study measures how many people reach a state of low disease activity or remission by week 52, and whether joint damage progresses.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
certolizumab pegol (an injectable biologic) combined with methotrexate (an oral medication)
What this could lead to
If successful, this combination could offer a new way to help people with early rheumatoid arthritis achieve lasting remission and slow joint damage.
What could go wrong
This is an early-stage test in a specific group of patients, and results may not apply to everyone. Possible risks include infections and allergic reactions from the biologic.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

880 people

The number who actually took part.

Start date

Jan 2012

Finished

Sep 2015

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects must have a time since diagnosis of adult-onset Rheumatoid Arthritis (RA) less than 1 year as defined by the 2010 ACR/EULAR classification criteria from Screening Visit * Positive Rheumatoid Factor (RF) and/or positive anticyclic Citrullinated Peptide Antibody (anti-CCP) * Active RA disease * DMARD-naïve * Subject is naïve to RA related biologics Exclusion Criteria: * A diagnosis of any other inflammatory Arthritis * History of infected joint prosthesis, or other significant infection and other serious medical condition * Known Tuberculosis (TB) disease or high risk of acquiring TB infection

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

Contacts and locations

Locations

  • 1

    Maroochydore, Queensland, Australia

  • 100

    Warsaw, Poland

  • 105

    Dudley, United Kingdom

  • 106

    Lund, Sweden

  • 108

    Brno, Czechia

  • 110

    Szombathely, Hungary

  • 111

    Bucharest, Romania

  • 113

    Berlin, Germany

  • 114

    Würzburg, Germany

  • 115

    Ferrara, Italy

  • 118

    Fribourg, Switzerland

  • 119

    York, United Kingdom

  • 120

    Berlin, Germany

  • 121

    London, United Kingdom

  • 122

    Milan, Italy

  • 123

    Malmö, Sweden

  • 124

    Bruntál, Czechia

  • 125

    Cannock, United Kingdom

  • 126

    Gilly, Belgium

  • 127

    Lingen, Germany

  • 128

    Bydgoszcz, Poland

  • 131

    Szolnok, Hungary

  • 132

    Ratingen, Germany

  • 158

    Mesquite, Texas, United States

  • 159

    Los Angeles, California, United States

  • 16

    Le Kremlin-Bicêtre, France

  • 160

    Covina, California, United States

  • 161

    Austin, Texas, United States

  • 162

    Dallas, Texas, United States

  • 163

    Palm Harbor, Florida, United States

  • 165

    Paradise Valley, Arizona, United States

  • 166

    Plantation, Florida, United States

  • 167

    Duncansville, Pennsylvania, United States

  • 168

    Wyomissing, Pennsylvania, United States

  • 17

    Bayreuth, Germany

  • 170

    Huntsville, Alabama, United States

  • 172

    Whittier, California, United States

  • 174

    Glendale, Wisconsin, United States

  • 175

    Nassau Bay, Texas, United States

  • 176

    Brooklyn, New York, United States

  • 177

    Hagerstown, Maryland, United States

  • 178

    Corpus Christi, Texas, United States

  • 179

    St Louis, Missouri, United States

  • 18

    Budapest, Hungary

  • 180

    Mobile, Alabama, United States

  • 181

    Lincoln, Nebraska, United States

  • 183

    Clarksburg, West Virginia, United States

  • 184

    Houston, Texas, United States

  • 185

    Amarillo, Texas, United States

  • 186

    Portland, Oregon, United States

  • 188

    Montreal, Quebec, Canada

  • 189

    Charleston, South Carolina, United States

  • 19

    Veszprém, Hungary

  • 190

    Fort Lauderdale, Florida, United States

  • 191

    Wichita, Kansas, United States

  • 192

    Sarasota, Florida, United States

  • 194

    Trois-Rivières, Quebec, Canada

  • 195

    Bethlehem, Pennsylvania, United States

  • 196

    Jupiter, Florida, United States

  • 197

    San Antonio, Texas, United States

  • 198

    Eagan, Minnesota, United States

  • 199

    Kalamazoo, Michigan, United States

  • 2

    Herson, Queensland, Australia

  • 200

    Vero Beach, Florida, United States

  • 201

    San Leandro, California, United States

  • 202

    Upland, California, United States

  • 203

    Tupelo, Mississippi, United States

  • 204

    Hendersonville, Tennessee, United States

  • 205

    Columbia, South Carolina, United States

  • 206

    Houston, Texas, United States

  • 207

    Albuquerque, New Mexico, United States

  • 209

    Birmingham, Alabama, United States

  • 21

    Budapest, Hungary

  • 210

    Wichita, Kansas, United States

  • 213

    Naples, Florida, United States

  • 214

    Ocala, Florida, United States

  • 215

    Cedar Rapids, Iowa, United States

  • 217

    Allen, Texas, United States

  • 22

    Bucharest, Romania

  • 223

    Houston, Texas, United States

  • 224

    South Bend, Indiana, United States

  • 226

    Coeur d'Alene, Idaho, United States

  • 227

    Rochester, New York, United States

  • 228

    Clifton, New Jersey, United States

  • 229

    Lebanon, New Hampshire, United States

  • 232

    Miami, Florida, United States

  • 233

    Kennewick, Washington, United States

  • 234

    Paradise Valley, Arizona, United States

  • 235

    Hamilton, Ontario, Canada

  • 236

    Durham, North Carolina, United States

  • 237

    Orange Park, Florida, United States

  • 238

    Lake Mary, Florida, United States

  • 24

    Iași, Romania

  • 240

    Kelowna, British Columbia, Canada

  • 241

    Oklahoma City, Oklahoma, United States

  • 242

    Plainview, New York, United States

  • 243

    Phoenix, Arizona, United States

  • 244

    Springfield, Illinois, United States

  • 245

    Middleburg Heights, Ohio, United States

  • 247

    Glendale, Arizona, United States

  • 249

    Plano, Texas, United States

  • 25

    Bucharest, Romania

  • 251

    Tucson, Arizona, United States

  • 255

    Orlando, Florida, United States

  • 256

    Reno, Nevada, United States

  • 257

    Hemet, California, United States

  • 26

    Bucharest, Romania

  • 27

    London, United Kingdom

  • 271

    Medellín, Colombia

  • 272

    Bogotá, Colombia

  • 276

    Buenos Aires, Argentina

  • 279

    San Juan, Argentina

  • 280

    Monterrey, Mexico

  • 281

    Durango, Mexico

  • 284

    Rosario, Argentina

  • 286

    Guadalajara, Mexico

  • 288

    Chía, Colombia

  • 291

    San Miguel de Tucumán, Argentina

  • 292

    Mexico City, Mexico

  • 293

    Bogotá, Colombia

  • 294

    San Luis Potosí City, Mexico

  • 297

    Bucaramanga, Colombia

  • 298

    Medellín, Colombia

  • 299

    Bogotá, Colombia

  • 3

    Malvern, Victoria, Australia

  • 302

    Mérida, Mexico

  • 303

    Barranquilla, Colombia

  • 32

    Limerick, Ireland

  • 33

    Cork, Ireland

  • 34

    Orléans, France

  • 36

    Kortrijk, Belgium

  • 37

    Prague, Czechia

  • 38

    Hradec Králové, Czechia

  • 4

    Geelong, Victoria, Australia

  • 40

    Reggio Emilia, Italy

  • 41

    Verona, Italy

  • 42

    Leiden, Netherlands

  • 44

    Wroclaw, Poland

  • 47

    Madrid, Spain

  • 49

    Rendsburg, Germany

  • 5

    Fitzroy, Victoria, Australia

  • 50

    Vienna, Austria

  • 51

    Brussels, Belgium

  • 52

    Bad Doberan, Germany

  • 53

    Planegg, Germany

  • 54

    Dublin, Ireland

  • 56

    Leeds, United Kingdom

  • 57

    Lasi, Romania

  • 58

    Brasov, Romania

  • 59

    Zerbst, Germany

  • 6

    Coffs Harbour, New South Wales, Australia

  • 61

    München, Germany

  • 63

    Santiago de Compostela, Spain

  • 65

    Yvoir, Belgium

  • 67

    Elblag, Poland

  • 68

    Sankt Gallen, Switzerland

  • 69

    Rheine, Germany

  • 7

    Perth, Western Australia, Australia

  • 70

    Frankfurt, Germany

  • 71

    Hamburg, Germany

  • 72

    Roma, Italy

  • 74

    Torun, Poland

  • 75

    Uppsala, Sweden

  • 76

    Gothenburg, Sweden

  • 77

    Stockholm, Sweden

  • 78

    Monaco, Monaco

  • 79

    Strasbourg, France

  • 8

    Woodville South, South Australia, Australia

  • 80

    Sheffield, United Kingdom

  • 81

    Hildesheim, Germany

  • 82

    Huddinge, Sweden

  • 85

    Le Mans, France

  • 86

    Eger, Hungary

  • 88

    Montpellier, France

  • 89

    Erfurt, Germany

  • 92

    Poznan, Poland

  • 93

    A Coruña, Spain

  • 99

    Krakow, Poland

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