Study: NCT01500278

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Certolizumab Pegol (CZP)
Description: * Active substance: an injectable volume of 1 ml solution for injection CZP~* Pharmaceutical form: prefilled syringes CZP~* Concentration: 200 mg/ml CZP~* Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Certolizumab Pegol (CZP)
Description: * Active substance: an injectable volume of 1 ml solution for injection CZP~* Pharmaceutical form: prefilled syringes CZP~* Concentration: 200 mg/ml CZP~* Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Certolizumab Pegol (CZP)
Description: * Active substance: an injectable volume of 1 ml solution for injection CZP~* Pharmaceutical form: prefilled syringes CZP~* Concentration: 200 mg/ml CZP~* Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Adalimumab (ADA)
Description: * Active substance: an injectable volume of 0.8 ml solution for injection ADA~* Pharmaceutical form: prefilled syringes ADA~* Concentration: 40 mg/0.8 ml ADA~* Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Adalimumab (ADA)
Description: * Active substance: an injectable volume of 0.8 ml solution for injection ADA~* Pharmaceutical form: prefilled syringes ADA~* Concentration: 40 mg/0.8 ml ADA~* Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Adalimumab (ADA)
Description: * Active substance: an injectable volume of 0.8 ml solution for injection ADA~* Pharmaceutical form: prefilled syringes ADA~* Concentration: 40 mg/0.8 ml ADA~* Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methotrexate (MTX)
Description: * Active substance: Methotrexate~* Pharmaceutical form: oral tablet~* Concentration: 15-25 mg/week~* Route of Administration: MTX orally

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methotrexate (MTX)
Description: * Active substance: Methotrexate~* Pharmaceutical form: oral tablet~* Concentration: 15-25 mg/week~* Route of Administration: MTX orally