A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluated how safe and effective ABBV-154 is in participants treated for moderately to severely active RA. Adverse events and change in the disease activity were assessed.
ABBV-154 is an investigational drug being evaluated for the treatment of RA. Study doctors placed the participants in 1 of 5 treatment groups or arms; each arm received a different treatment. There was a 1 in 5 chance that participants were assigned to placebo. Participants 18-75 years of age with moderate to severe RA were enrolled. Around 425 participants were to be enrolled in the study at approximately 270 sites worldwide.
The study was comprised of a 12 week placebo-controlled period, a double-blind long term extension (LTE) period 1 of 66 weeks, a LTE period 2 of 104 weeks and a follow-up visit 70 days after the last dose of the study drug. In the LTE period 1, participants in the placebo group were re-randomized to receive ABBV-154 at 1 of 2 different doses SC every other week (EOW). Other participants remained on their previous dose and dosing regimen of ABBV-154.
There may have been a higher treatment burden for participants in this trial compared to their standard of care. Participants attended regular visits during the study at a hospital or clinic. The effect of the treatment was checked by medical assessments, blood tests, and side effects, and completing questionnaires.
Participants were randomly assigned at a ratio of 1:1:1:1:1 to ABBV-154 at either 40 mg, 150 mg, 340 mg, subcutaneously (SC) EOW; 340 mg SC every 4 weeks (E4W); or placebo SC EOW. Randomization was stratified by baseline glucocorticoid (yes/no); number of prior failed biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) (1; 2 or more); and prior anti-TNF failure (yes/no) and if yes, further stratification by prior adalimumab use (yes/no).
After 12 weeks, participants receiving placebo were re-randomized to receive ABBV-154 150 mg SC EOW or 340 mg SC EOW for the long-term extension (LTE) periods. At re-randomization, participants were stratified by baseline glucocorticoid use (yes/no) and prior adalimumab use (yes/no). Participants from the other dose groups were to continue with their respective dose and dosing regimen.
The primary analysis was conducted after all ongoing participants completed Week 12 or withdrew from the study. A final analysis was to be conducted after all participants completed LTE period 2 and a safety follow-up visit or withdrew from the study. The study was terminated before any participants entered LTE Period 2.
Inclusion Criteria:
Exclusion Criteria:
- Participant discontinued prior adalimumab therapy due to intolerability or toxicity.
Los Angeles, California 90045-6200, United States
Torrance, California 90502, United States
Boca Raton, Florida 33486, United States
Skokie, Illinois 60076, United States
Tupelo, Mississippi 38801-4949, United States
St Louis, Missouri 63119-3845, United States
Voorhees Township, New Jersey 08043, United States
Orchard Park, New York 14127, United States
Oklahoma City, Oklahoma 73102, United States
Cranberry Township, Pennsylvania 16066, United States
Wyomissing, Pennsylvania 19610, United States
Allen, Texas 75013-6147, United States
Carrollton, Texas 75007, United States
Saskatoon, Saskatchewan S7H 5M7, Canada
Budapest, Pest County 1036, Hungary
Veszprém, 8200, Hungary
Nagoya, Aichi-ken 455-8530, Japan
Asahikawa-shi, Hokkaido 078-8243, Japan
Kato-shi, Hyōgo 673-1462, Japan
Sanuki-shi, Kagawa-ken 769-2393, Japan
Sasebo-shi, Nagasaki 857-1195, Japan
Nagaoka-shi, Niigata 940-2085, Japan
Kawachinagano Shi, Osaka 586-8521, Japan
Sayama-shi, Saitama 350-1305, Japan
Chuo-ku, Tokyo 104-8560, Japan
Meguro-ku, Tokyo 152-8902, Japan
Sumida-ku, Tokyo 130-0013, Japan
Shimonoseki-shi, Yamaguchi 752-0976, Japan
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168, Poland
Gdansk, Pomeranian Voivodeship 80-546, Poland
Korolev, Moscow 141060, Russia
Moscow, Moscow Oblast 129110, Russia
Cheonan-si, Chungcheongnam-do 31151, South Korea
Seoul, Seoul Teugbyeolsi 03722, South Korea
Santiago de Compostela, A Coruna 15706, Spain
Sihhiye, Ankara 06100, Turkey (Türkiye)
Kyiv, 02091, Ukraine
Poltava, 36011, Ukraine
Vinnytsia, 21018, Ukraine